Generic drug approvals. Medical search. Frequent questions

Our report, based on 40 generic medications that were approved from 2017-2018, clearly shows that generic drug approvals often don't lead to greater affordability or even access here in the U.S. We were inspired to examine pricing in addition to availability after seeing availability research conducted by Kaiser Health News (KHN). (pharmacycheckerblog.com)
The generic drugs market is estimated to have reached $257.3bn in 2018 and is expected to grow at a CAGR of 8.8% in the first half of the forecast period. (visiongain.com)
Asia-Pacific held 31% of the generic drugs market in 2018. (visiongain.com)
What were the market shares of the leading national markets in the global generic drugs market in 2018? (visiongain.com)
Which particular national markets will be the main drivers of growth in the global market for generics from 2018 to 2029? (visiongain.com)
Drafted by the Ethics, Law, and Humanities Committee - a joint committee that includes the AAN, the American Neurological Association, and the Child Neurology Society - the statement was prompted by a 2018 report from the AAN Neurology Drug Pricing Task Force to address challenges associated with high drug costs. (medscape.com)

In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market entry of generic drugs. (patexia.com)
The Abbreviated New Drug Application (ANDA) is a regulatory pathway in the United States that allows for the approval of generic versions of brand-name drugs. (patexia.com)
ANDA litigation arises when a generic drug manufacturer files an ANDA and challenges the validity or enforceability of the patents associated with the reference listed drug. (patexia.com)
ANDA litigation represents a delicate balance between promoting innovation in the pharmaceutical industry and ensuring timely access to affordable generic drugs. (patexia.com)
Thanks in large part to new elemental impurities requirements, ANDA approvals are behind the pace needed to beat 2017's record. (citeline.com)
Is Bloom Gone From Rosy ANDA Approvals Figures? (citeline.com)
Reports include only BLAs/NDAs/ANDAs or supplements to those applications approved by the Center for Drug Evaluation and Research (CDER) and tentative NDA/ANDA approvals in CDER. (fda.gov)
A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). (drugs.com)

By comparison, the European Medicines Agency, Europe's version of the FDA, has just 24 generics, including biologically based biosimilars awaiting approval. (wfdd.org)
The FDA's generic count doesn't include biosimilars, which are more complicated medicines to review. (wfdd.org)
FDA relates new record to its plan to increase access to affordable drugs, but Association for Accessible Medicines says approvals alone will not increase competition. (citeline.com)
Most prior research has found little difference between generics and name-brand medicines, and there may be other factors at work in this study that could have affected the results, says Dr. Choudhry. (harvard.edu)
The result: Many patients are forced to take high-price medicines, and a widely touted remedy for reining in drug costs has failed to live up to its promise. (kffhealthnews.org)
Between January and October 2013, the whistle-blower sent 15 emails to the United States Food & Drug Administration (USFDA), the World Health Organization (WHO), the Austrian Agency for Health and Food Safety (AGES) and the National Agency for Medicines and Health Products Safety (ANSM), requesting them to audit the facility. (thehindu.com)
The Indian generic drug-makers had countered by accusing big pharma of using patents as an excuse to keep affordable Indian medicines from the access of poor patients. (thehindu.com)
The 1984 drug-patent-reform law known as the Hatch-Waxman Act gave Americans greater access to generic medicines. (aao.org)
India's growing importance in the US supply of generic medicines prompted the FDA to increase its workforce in the country to 19 from 12 in recent years. (livemint.com)
India's growing importance in the US supply of generic medicines-India Ratings & Research estimates it accounted for 31% of all new drug approvals last year-prompted the FDA to increase its workforce in the country to 19 from 12 in recent years. (livemint.com)
Meanwhile the larger companies are graduating into more complex, higher-margin medicines, which means pouring more resources into fewer, but more valuable, approvals, he said. (livemint.com)
Biotech drugs are powerful, injected medicines produced in living cells. (foxbusiness.com)
The Doha Declaration on the TRIPS Agreement and Public Health reflects WTO Members' appreciation of the correct balance between patent protection and provision of incentives for drug development and access to medicines. (who.int)
In the case of the WTO General Council's Decision of 30 August 2003, which adopted a system to enable the import and export of medicines produced under compulsory licence, some prospective exporting countries have initiated the process of amending national laws to enable export by generic manufacturers, as most national laws do not allow the supply of export markets under compulsory licences. (who.int)
To assess the quality of selected medicines, samples were collected from random private drug outlets of Dhaka North and South City Corporation, Bangladesh. (bvsalud.org)
and Denmark's Medicines Authority has approved first-time generic formulations of cefuroxime axetil 250- and 500-mg tablets for the treatment of indicated infections caused by susceptible microorganisms. (medscape.com)
Rational use of medicines for all medical features of health care facilities that im- lines and methods to ensure reliabil- conditions is fundamental to the provi- pact on rational drug prescribing and ity of data collection. (who.int)

Drugs may be covered by multiple patents or regulatory protections. (drugpatentwatch.com)
The model uses a combination of Machine Learning (ML) and a GlobalData proprietary algorithm to process data points from the Drugs, Clinical Trials, Regulatory Milestones, Company, and Financial databases. (globaldata.com)
For prescription brand-name drugs, Drugs@FDA typically includes the most recent labeling approved by the FDA (for example, Prescribing Information and FDA-approved patient labeling when available), regulatory information, and FDA staff reviews that evaluate the safety and effectiveness of the drug. (fda.gov)
In 2016, the German regulatory authority BfArM officially confirmed the formulation of the generic Skinatan ® pharmaceuticals in four different topical dosage forms (solution, emulsion, cream and ointment). (dermago-group.com)
The police, during the investigation, went through the employee's emails and found that he had written to every major drug regulatory authority in the world raising doubts about the quality of clinical research conducted at GVK Biosciences. (thehindu.com)
That changed in 2012 when the FDA laid out a regulatory pathway to approve the drugs, known as 'biosimilars. (foxbusiness.com)
Then, in late October 2019, the companies indicated that after discussions with the U.S. Food and Drug Administration (FDA), and further analysis of the data, they were going to pursue regulatory approval for the drug. (biospace.com)
The FDA's regulatory authority is enormous, ranging from food and food safety to prescription drugs and biologics, blood and blood products, over the counter medications and dietary supplements, as well as cosmetics, medical devices, tobacco, and veterinary products. (heritage.org)
The federal Affordable Care Act authorized the FDA to develop a regulatory framework for approval of biosimilars. (scienceblog.com)
Innovative regulatory and legislative measures to stimulate and facilitate the development of new antimicrobial drugs are needed. (cdc.gov)
We also outline current and future measures that regulatory agencies may employ to help control resistance and promote drug development. (cdc.gov)
However, in an era of emerging drug resistance, controlled clinical data are often not available to guide regulatory policy. (cdc.gov)
In the second half, we outline measures that regulatory agencies may use to help control resistance and facilitate drug development. (cdc.gov)
These experts from regulatory, academic, and private sectors discussed bioequivalence standards, existing and emerging efforts to promote quality in brand and generic manufacturing, as well as market-based solutions throughout the drug supply chain. (bvsalud.org)

Welcome to the Taj Pharma India generics portfolio. (tajgenerics.com)
Skin Care Pharma GmbH, a company of Dermago Verwaltungs GmbH, announces that yet another milestone has been reached in the development and approval of Skinatan ® 1 mg/g Emulsion for cutaneous application with the active ingredient methylprednisolone aceponate (MPA). (dermago-group.com)
Within the next few weeks, Skin Care Pharma GmbH and its license partners are to be granted marketing approval for Skinatan ® 1 mg/g Emulsion by the respective national authorities. (dermago-group.com)
Skin Care Pharma GmbH specializes in the development of semi-solid pharmaceuticals as generic versions. (dermago-group.com)
For the further development of Skinatan ® Cream and Ointment, Skin Care Pharma GmbH was able to successfully complete two pivotal clinical studies and has already applied for marketing approval of both formulations in seven European countries by means of a decentralized procedure (DCP). (dermago-group.com)
A recent report by HSBC analyst Girish Bakhru named Aurobindo Pharma as a company that has witnessed a higher number of approvals. (indiatimes.com)
But even as the FDA has increased scrutiny of India, it's been approving generic drug applications from the country's firms at a record pace, with smaller companies like Aurobindo Pharma Ltd and Glenmark Pharmaceuticals Ltd leading the pack. (livemint.com)
On Wednesday, Sun Pharma, Glenmark and Aurobindo said they had received approval to sell generics of the AstraZeneca Plc's blockbuster cholesterol pill Crestor in the US. (livemint.com)

Warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products to treat conditions such as conjunctivitis, cataracts, glaucoma, and others. (acpinternist.org)
Why have prices for ophthalmic generics skyrocketed over the last two years, and why are some in short supply? (aao.org)

While expected to produce less-dramatic savings than an earlier generation of less-complex generic drugs, the introduction of biosimilars into the U.S. marketplace is expected to increase competition and drive down prices, resulting in savings for patients, health care payers and taxpayers. (scienceblog.com)
In addition, nearly all biosimilars will require at least one head-to-head clinical trial to confirm similarity to the original biologic, a more-strenuous process than required for standard generics. (scienceblog.com)
In order to create an estimate of the likely savings from biosimilars, RAND researchers created a framework to predict future use of the drugs, considering issues such as the effect of increased competition and acceptance of biosimilars by physicians, patients and payers. (scienceblog.com)
The effort included examining the experience with biosimilar drugs in the European Union, where an approval process was created a decade ago and several biosimilars already have been approved. (scienceblog.com)
Among those issues is how much future use of biologics grows as some patients decide to switch to the drugs once biosimilars make such treatment more affordable. (scienceblog.com)

As of July 1, the FDA had 4,036 generic drug applications awaiting approval , and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, a trade group. (wfdd.org)
Leading international experts will gather at the University of Bradford's Institute for Pharmaceutical Innovation (IPI) for a conference looking at how cutting-edge computer techniques can be used to develop drugs. (news-medical.net)
Canadian health groups urge ban on exportation of pharmaceutical drugs from Canada to the U.S. (news-medical.net)
Canadian health groups today called on the Government of Canada to ban the exportation of pharmaceutical drugs from Canada to the U.S. The groups, who represent the interests of millions of Canadian patients, were in Washington to highlight their concerns with Internet pharmacies. (news-medical.net)
National Autism Association announced Tuesday that the Centers for Disease Control (CDC), Food and Drug Administration (FDA) and some pharmaceutical companies have become a target for investigation. (news-medical.net)
Innovator drug companies obtain patents to safeguard their inventions, including the active pharmaceutical ingredient, formulation, manufacturing processes, and other related aspects. (patexia.com)
Pharmaceutical company Lupine announced Monday that it has received approval from the US Food and Drug Administration to commercialize tenofovir alafenamide tablets in the US market to treat chronic hepatitis B virus infection. (peppystores.com)
Read about pharmaceutical development and pricing stories in this week's Prescription Drug Watch round up. (kffhealthnews.org)
Drugs don't work if people can't afford to take them, he said, and the pharmaceutical company's $225,000-a-year price was well out of bounds. (kffhealthnews.org)
Drug pricing regulations would not decimate the pharmaceutical industry, according to an analysis from health policy researchers at West Health and Johns Hopkins. (kffhealthnews.org)
It only leaves doubt about its intention," said D.G. Shah, secretary-general of Indian Pharmaceutical Alliance (IPA), a lobby of domestic drug-makers. (thehindu.com)
I have repeatedly stated that multinational pharmaceutical companies constantly use incidents like this to bring disrepute to Indian generic drug makers," he said. (thehindu.com)
That increased presence was felt last year as the nation's two largest pharmaceutical companies, Sun Pharmaceutical Industries Ltd and Dr. Reddy's Laboratories Ltd, along with a number of smaller firms, received warning letters on some of their plants from the FDA, restricting future approvals for products made at those sites until the regulator's concerns are addressed. (livemint.com)
The approval and regulation of the pharmaceutical industry is a process heavily financed by "user fees" imposed on pharmaceutical companies. (heritage.org)
It highlights ethical concerns from high drug costs, policy proposals that might temper the problem, and how clinicians can adjust to the current reality of pharmaceutical pricing and better advocate for changes to the healthcare system. (medscape.com)
The study was conducted retrospectively over a 7-year period (2011-2017) for non-sterile generic products that were finalised by the Pharmaceutical and Analytical pre-registration Unit. (bvsalud.org)

Other off-patent drugs with rising prices and no generic competition have also drawn scrutiny, including Turing Pharmaceuticals' Daraprim, for toxoplasmosis, and Valeant's cardiovascular drugs Isuprel and Nitropress. (wfdd.org)
In March, generics giant Teva Pharmaceuticals told investors that its generic version of EpiPen was rejected by the FDA, and that it wouldn't be able to launch the generic until at least 2017. (wfdd.org)
Adamis Pharmaceuticals reported a similar rejection from the FDA for its EpiPen generic in June. (wfdd.org)
Maxim Pharmaceuticals today announced that its treatment protocol to provide its investigational drug Ceplene(TM), in combination with interleukin-2 (IL-2), for the treatment of patients with advanced malignant melanoma, has been approved by the U.S. Food and Drug Administration (FDA). (news-medical.net)
Novartis Pharmaceuticals Corporation announced today that the company will work with Medicare-approved drug discount card sponsors to provide its products free of Novartis charges to low-income Medicare enrollees, after they have exhausted their $600 transitional assistance available from the government. (news-medical.net)
We are committed to developing a distinguished generics pharmaceuticals business. (tajgenerics.com)
EXPERT OPINION: The time spent understanding bioequivalence standards during the seminar felt especially important and relevant in our current pandemic environment, given the present need to have confidence in the science of drug development and to advocate for the safety of pharmaceuticals. (bvsalud.org)

A generic drug is an exact copy of the active drug in a brand-name medication. (medicalnewstoday.com)
It is available as a generic medication. (wikipedia.org)
In order to get a stamp of approval from the FDA, a generic medication must be "bioequivalent" to its brand-name counterpart. (harvard.edu)
For example, the manufacturer of a generic blood pressure medication wouldn't need to prove that its drug also lowers blood pressure, says Dr. Choudhry. (harvard.edu)
FDA's review process ensures that generic medications perform the same way in the human body and have the same intended use as the name brand medication. (fda.gov)
The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. (drugs.com)
Today, the price tags are $60 and $100, respectively, for the same size bottles and this is a generic medication. (aao.org)
She has a number of patients who have rationed their medication or stopped taking it altogether when their co-pays increased or they lost access to a co-pay assistance program because their insurance company chose to cover a still-expensive generic drug with no assistance program over a slightly costlier brand-name medication that comes with patient discounts. (medscape.com)
Generic drug names were used in only 15.1% and strength of medication and dose units were included in 26.6% and 55.6% of prescriptions. (who.int)

Supplement #: NDA 205388 006 Drug Name: Omidria™ ( Phenylephrine HCL/Ketoroloc Tromethamine) Indication(s): … NDA supplement was a pediatric use supplement. (fda.gov)
Reimburse · The drug under review demonstrates comparable or added clinical benefit and acceptable cost/cost- effectiveness relative to one or more appropriate comparators to recommend reimbursement in accordance with the defined patient population under review, which is typically the patient population defined in the Health Canada-approved indication (as applicable). (bvsalud.org)
with · The drug under review demonstrates comparable or added clinical benefit and acceptable cost/cost- clinical effectiveness relative to one or more appropriate comparators in a subgroup of patients within the criteria approved indication. (bvsalud.org)

Reacting to the ban by European drug regulators, the Commerce Ministry said in a release that it was "disappointed by and concerned" at the ban on "one of the flagship sectors of India", as the story snowballed into the latest setback to the reputation of India-made generic drugs. (thehindu.com)
G.N. Singh, Drug Controller-General of India (DCGI), confirmed that he knew about the whistle-blower. (thehindu.com)
In 2003 the Government of Malaysia used the "Rights of Government" provision in the national patent law to allow the import of generic antiretroviral agents from India for use in public hospitals. (who.int)

The FDA's approach to regulating small-molecule generic drugs cannot be applied to biologicals, which are complex molecules manufactured in living systems. (scienceblog.com)

A few big companies, however, are lagging in terms of approvals like Dr. Reddy's, Sun and Cadila. (indiatimes.com)
Dr Reddy's, similarly, is seeing a delay in approvals of big-ticket drugs owing to observations cited by the FDA at its Srikakulam site in Andhra Pradesh. (indiatimes.com)
In the first six months of this year, Sun received about five new generic drug approvals, while Dr. Reddy's received one, according to the data. (livemint.com)

Health care professionals and consumers can be assured that FDA-approved generic drug products have met the same rigid standards as the innovator drug. (fda.gov)

Consumers and lawmakers pushing for cheaper alternatives to the EpiPen, an antidote for life-threatening allergic reactions, and other high-priced drugs are seeking answers about a stubborn backlog of generic drug applications at the Food and Drug Administration. (wfdd.org)
Dr. James Baker, the CEO and chief medical officer of the advocacy group Food Allergy and Research Education, said Mylan's move may deter other generic manufacturers from seeking approval. (wfdd.org)
Mylan Inc. said Tuesday that the Food and Drug Administration approved the drugmaker's generic version of the high blood pressure treatment Teveten. (missouripartnership.com)
A record number of generic drugs were approved by the Food and Drug Administration last year. (ushealthcarecosts.com)
The Food and Drug Administration (FDA) has been working to clear a backlog of applications for generic drugs. (ushealthcarecosts.com)
The company has received provisional approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for tenofovir alafenamide tablets (25 mg), Lupine said in a statement. (peppystores.com)
Piqray was approved by the Food and Drug Administration (FDA) in 2019 to treat a specific type of breast cancer. (medicalnewstoday.com)
The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. (medicalnewstoday.com)
A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions. (news-medical.net)
Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. (news-medical.net)
The Food and Drug Administration (FDA) today announced the tentative approval of the generic version of Abacavir Sulfate Oral Solution. (news-medical.net)
citation needed] Cabazitaxel was developed by Sanofi-Aventis and was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hormone-refractory prostate cancer in June 2010. (wikipedia.org)
A new device that drains a portion of a person's stomach contents after every meal has just won approval from the U.S. Food and Drug Administration. (thefiscaltimes.com)
The Food and Drug Administration's oversight of the U.S. food industry is severely lacking, with shortcomings so. (thefiscaltimes.com)
of the Federal Food, Drug, and Cosmetic Act for OMS302 ( phenylephrine -ketorolac injection) 1%/0. (fda.gov)
To obtain needed pediatric information on phenylephrine and ketorolac , the Food and Drug … you submit information from the study described below. (fda.gov)
The drug, Pfizer Inc.'s tafamidis, cost $651 a day, Maurer told them-equal to a patient's food budget for a month. (kffhealthnews.org)
A backlog of as many as 4,000 pending applications at the US Food and Drug Administration (USFDA), of which a fourth is estimated to have been filed by Indian firms, is awaiting clearance. (indiatimes.com)
The U.S. Food and Drug Administration (FDA) is limited in what it can do to ameliorate the drug shortages, and it has no power by law over prices, said Marcia Crosse, PhD, director of the health care group of the U.S. Government Accountability Office (GAO). (aao.org)
The US Food and Drug Administration (FDA) has become something of a bogeyman for India's stock market. (livemint.com)
Over the last year, the Food and Drug Administration has paved the way for adults and children to receive the COVID-19 vaccine as protection against the deadly coronavirus. (ktvu.com)
The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize the pill's safety and effectiveness in late November. (ktvu.com)
On March 14, 2022, the Food and Drug Administration (FDA) issued a notice entitled, Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2022 . (alston.com)
The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. (alston.com)
A couple weeks ago, President Donald Trump nominated Dr. Scott Gottlieb to be commissioner of the powerful Food and Drug Administration. (heritage.org)
The U.S. Food and Drug Administration is developing regulations to govern the approval process for highly similar versions of the already-approved complex, protein-based biologics, which includes drugs such as insulin, monoclonal antibodies and a range of medications to treat other serious conditions. (scienceblog.com)
The U.S. Food and Drug Administration (FDA) sets bioequivalence standards for different drug dosage forms. (msdmanuals.com)
US Food and Drug Administration approvals of systemic antibacterial new molecular entities, 1980-2004. (cdc.gov)
The study will enroll patients with all forms of wet AMD who are being treated with intravitreal bevacizumab ( Avastin , made by Genentech, Inc). The product was deemed "approvable" by the US Food and Drug Administration in May 2005. (medscape.com)

As an option for those who cannot afford that, PharmacyChecker found that 25% of the generic medications were available online, internationally through pharmacies that are accredited in the PharmacyChecker Verification Program . (pharmacycheckerblog.com)
A drug class is a group of medications that work in a similar way. (medicalnewstoday.com)
Many people have the same questions about generic prescription medications, says Dr. Niteesh K. Choudhry, professor of medicine at Harvard Medical School and executive director of the Center for Healthcare Delivery Sciences at Brigham and Women's Hospital. (harvard.edu)
It found that patients who took generic versions of three different blood pressure medications in the months after the generic drugs became available saw increased rates of drug-related side effects. (harvard.edu)
In addition, generic medications can play an important role in reducing health care costs and improving access to care, he says. (harvard.edu)
Before we get into specifics about past research and the findings of this recent study, let's talk a little about the overall quality of generic medications, including how they are regulated and approved. (harvard.edu)
A large number of studies (albeit mostly small ones) have looked at whether specific generic medications are the same as the brand-name originals, he says. (harvard.edu)
This brings us to the Canadian study that seems to show differences between generic and brand-name medications. (harvard.edu)
While it didn't examine how well these medications performed when it came to reducing blood pressure, it did raise the question of whether patients experienced more serious side effects from the generic medications than the original versions of the blood pressure drugs researchers looked at. (harvard.edu)
They examined data for the periods 24 months before and 12 months after the generic versions of these medications went on the market. (harvard.edu)
Why it matters: This throws some cold water on Big Pharma's claims that new drug research and investments would evaporate if the federal government limits what they can charge for medications - the proposal du jour in Congress and the White House. (kffhealthnews.org)
Today, about 80 percent of the prescription medications purchased are less expensive, generic versions of brand-name drugs. (aao.org)
Biotech drugs have never faced generic competition in the United States because the FDA did not have a system to approve copies of such medications. (foxbusiness.com)
In 2011, eight of the top 20 drugs in the United States in terms of sales were biologics and the annual spending on the drugs has grown three times faster than other prescription medications. (scienceblog.com)
Out-of-pocket costs for neurologic medications have risen dramatically over the past decade, with the fastest rise reported among drugs for multiple sclerosis. (medscape.com)
Medications are drugs used therapeutically (that is, to treat medical conditions). (msdmanuals.com)

GlaxoSmithKline has announced it would supply 90,000 packs of its antiretroviral drugs Combivir, Epivir and Ziagen to Russia at discounted prices by the end of 2006, the AFP/Yahoo! (news-medical.net)
The standard of care in Human Immunodeficiency Virus (HIV) infection is the use of a triple drug antiretroviral regimen. (who.int)
The success of complex antiretroviral regimens is dependent on consistent adherence of patients to the drugs. (who.int)
HA060 trade name] is a generic version of Combivir®, the first fixed-dose combination containing two known antiretroviral agents belonging to the RT inhibitors class. (who.int)

Executives had misleading stated that Teva's profits were achieved despite significant competition in the generics market, when in fact Teva and its competitors were engaged in an industry wide price-fixing scheme. (schneiderwallace.com)
US FDA sets a new monthly record for full approvals, but industry group argues that approvals alone aren't creating more generic competition in the market. (citeline.com)
Record numbers of generic drugs for cancer, heart ailments and other conditions have received U.S. approval in recent years, raising hopes that the new competition would reduce high drug costs. (kffhealthnews.org)
A decision on whether to open a costly cancer drug to generic competition will be made shortly. (prospect.org)
After that, generic companies could market their versions and create competition on price. (prospect.org)
Inventive (but legal) strategies that allow manufacturers of brand-name drugs to circumvent the limitations of a 30-year-old federal law that was intended to increase competition from generics and level the playing field. (aao.org)
Gottlieb, like the president, believes that the current drug markets are dysfunctional and wants to intensify competition. (heritage.org)
Force manufacturers to include prescription drug prices in their DTC ads to encourage competition. (mmm-online.com)

In addition to data analysis of the generic drug prices and those of their brand counterparts, we provide insight on why generics are approved but don't seem to be available. (pharmacycheckerblog.com)
The 246-page report provides clear detailed insight into the generic drugs market. (visiongain.com)

Aurobindo has gained 17 FDA approvals so far this year, second in the chart among Indian firms. (indiatimes.com)
Glenmark, meanwhile, has won 10 new approvals in that period and Aurobindo has received 28. (livemint.com)
That follows on from strong momentum for the companies last year, when Glenmark won approval for a generic version of Merck and Co.'s $2.5 billion a year cholesterol drug Zetia, and Aurobindo got the go-ahead for a generic version of heart-disease drug Integrilin. (livemint.com)

At a recent appointment, Katz Sand learned about a patient's drug rationing only after a routine MRI showed new brain lesions that regular treatment might have prevented. (medscape.com)
The purpose of this study was to screen drug prescriptions written by physicians in A drug prescription is often the endpoint of outpatient clinics of Asir Central Hospital a patient's visit to a medical practitioner. (who.int)

While the first two years of the plan did not show a perceptible change in terms of faster approvals, the FDA had shared details on industry forums about additional hiring for review processes and investments made to accelerate the pace of approvals. (indiatimes.com)
In the first half of this year, the pace of approvals slowed to 72 through June, still among the best six-month periods in data going back to 2005. (livemint.com)
In part, the relative pace of new approvals between the companies reflects an inevitable maturation of India's drug industry, according to PhillipCapital's Patra. (livemint.com)

Adrenaclick is the only other epinephrine auto-injector on the market, but it isn't an exact generic of EpiPen and can't be swapped automatically at the pharmacy if a doctor has written a prescription for EpiPen. (wfdd.org)
Recalled products were contained in health essentials kits distributed by Humana to its members and contain an incomplete prescription drug label rather than the required over-the-counter (OTC) drug facts label. (acpinternist.org)
The combination of an aging population, rising medical service costs and staggering increases in prescription drug. (thefiscaltimes.com)
One of the largest groups for doctors in the U.S. is calling for new health care oversight in an effort to counter high prescription drug costs. (kffhealthnews.org)
Any day now, the National Institutes of Health will render a decision that will signal whether the Biden administration is serious about using all available tools to lower the cost of prescription drugs. (prospect.org)
The fact that President Biden is speaking about prescription drug prices in Virginia on Thursday could signal a favorable result. (prospect.org)
With the Build Back Better Act, which included prescription drug pricing reform, flailing, march-in rights and a similar measure under Section 1498 of the U.S. Code (often called "eminent domain for patents") offer an alternative to make progress on lowering prices , without needing congressional approval. (prospect.org)
Sometimes the price is high but it's high everywhere," said James Love of Knowledge Ecology International , a nonprofit that advocates for greater prescription-drug access. (prospect.org)
Prescription drug testing and approval is the agency's biggest headline-grabbing task. (heritage.org)
Gottlieb is taking over the FDA at the very time that there is deep concern in the White House, Congress, and the nation over rising prescription drug prices. (heritage.org)
Lower drug prices by streamlining the approval of prescription to OTC conversions. (mmm-online.com)
Besides, experience with NSAIDs, allergy meds, and proton pump inhibitors has shown any OTC version of these drugs will cost far more than the prescription versions covered by insurance. (mmm-online.com)
More than 7100 monographs are provided for prescription and over-the-counter drugs, as well as for corresponding brand-name drugs, herbals, and supplements. (medscape.com)
Generics that deliver 4 mg/actuation are also prescription. (medscape.com)

Mylan has said it will offer a $300 generic in the coming weeks. (wfdd.org)
Because Mylan also makes the brand-name product, it won't have to wait in line behind other pending generics. (wfdd.org)
And documents show that Mylan submitted a citizen petition to the FDA arguing that people trained to use EpiPens wouldn't be able to use Teva's pending generic epinephrine auto-injector because of design differences. (wfdd.org)
This could open the way for Mylan to launch generic versions of the drug. (biospace.com)

and tentative approvals of ANDAs and NDAs. (fda.gov)

The purpose of this study was to estimate the cost of generic drug development and approval. (hhs.gov)
This study develops an analytical framework for examining the expected net present value (ENPV) (i.e., the difference between the present value of expected revenues over product life and cost of product development and approval) to a generic drug developer in different size drug markets. (hhs.gov)
The developed framework forms the basis for an accompanying operational model that enables the user to specify numerous details of a generic drug development project and provides cost, revenue, and ENPV estimates for the project being examined. (hhs.gov)
Many patients were in the dark about EpiPen price increases until insurers started shifting more of the cost onto consumers a few years ago, and getting approval for a generic that's both a drug and a device is more complicated than getting approval for a drug alone, he said. (wfdd.org)
The KHN article concluded that the lack to generic availability in the U.S. "means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month. (pharmacycheckerblog.com)
Of those, 23 brand-name drugs available internationally cost on average 74% less than the brand version sold in the U.S. (pharmacycheckerblog.com)
Of those, 14 of the brand-name drugs available internationally cost on average 73% less than the U.S. generic versions . (pharmacycheckerblog.com)
Generics usually cost less than brand-name drugs. (medicalnewstoday.com)
Federal health officials say they approved the first lower-cost copy of a biotech drug, a long-awaited milestone that could generate billions in savings for insurers, doctors and patients. (foxbusiness.com)
They typically cost much more than traditional, chemical-based drugs. (foxbusiness.com)
The price of the new generic will be $137.35 per vial, or 50% of the cost of the branded version. (ajmc.com)
Are we ready to legislate how much a life-saving drug should cost? (mmm-online.com)
The drug under review demonstrates comparable clinical benefit and acceptable cost/costeffectiveness conditions relative to one or more appropriate comparators. (bvsalud.org)
The drug under review demonstrates comparable or added clinical benefit, but the cost/cost- effectiveness relative to one or more appropriate comparators is unacceptable. (bvsalud.org)

Are generic drugs really the same quality, or is it better to spend more for the name-brand version? (harvard.edu)
However, while companies are required to get the chemical recipe of the generic drug close to the original, they aren't required to show that the two versions are therapeutically equivalent, meaning that they don't have to do tests to make sure that patients respond to these drugs the same way they do the brand-name version. (harvard.edu)
Has a generic version of Definity RT been approved? (drugs.com)
Fraudulent online pharmacies may attempt to sell an illegal generic version of Definity RT. (drugs.com)
Last week, the company disclosed of an approval, its third in five days, for a delayed release version of gastric ulcer and heartburn drug omeprazole. (indiatimes.com)
In those cases the generic version saves only about 20 percent, apparently because there is only one manufacturer, he said. (aao.org)
version of the blockbuster drug Neupogen, which is used to boost blood cells in cancer patients and had $839 million in U.S. sales last year. (foxbusiness.com)
When one company develops a generic version of another company's brand-name drug, the new company's experts in drug formulation must figure out how to make the drug. (msdmanuals.com)
However, because inactive ingredients can cause unusual and sometimes severe allergic reactions in a few people, one version, or brand, of a drug may be preferable to another. (msdmanuals.com)
Manufacturers must conduct studies to determine whether their version is bioequivalent to the original drug-that is, that the generic version releases its active ingredient (the drug) into the bloodstream at virtually the same speed and in virtually the same amounts as the original drug. (msdmanuals.com)
Because the active ingredient in the generic drug has already been shown in testing of the brand-name drug to be safe and effective, bioequivalence studies only have to show that the generic version produces virtually the same levels of drug in the blood over time and thus require only a relatively small number (24 to 36) of healthy volunteers. (msdmanuals.com)

By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. (drugs.com)

This column reviews details on recent recalls, alerts, and approvals. (acpinternist.org)

This increase in generics, which are usually cheaper and more widely used than their brand name counterparts, is a boon for consumers, experts say. (ushealthcarecosts.com)
The brand in the U.S. is cheaper than the U.S. generic for 3 of the drugs. (pharmacycheckerblog.com)
Based on his published record, he favors accelerated approval of cheaper generic drugs, and the streamlining of drug approvals generally. (heritage.org)

However, the presence of patents related to the RLD can complicate the approval process. (patexia.com)
The Trump administration has pushed to speed up the approval process for generic drugs as part of its strategy to lower. (thefiscaltimes.com)
What Is the Approval Process for Generic Drugs? (fda.gov)
The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. (drugs.com)
As part of a fixed five-year plan, the Generic Drug User Fee Amendments were initiated in 2012 in the US to facilitate a speedy approval process, with industry players paying a fee to supplement costs of reviewing the applications and inspecting facilities. (indiatimes.com)
Lupin has emerged as the biggest beneficiary of the GDUFA process as the company gained approvals for 19 products in 2015. (indiatimes.com)

Will the drug transition to the next phase of its clinical pathway? (globaldata.com)

However, the intersection of patents and generic drug approvals can be a complex and challenging landscape. (patexia.com)
These may include the strength and scope of the patents in question, the quality and reliability of scientific evidence presented, the expertise of legal counsel, the interpretations of claim terms, and the potential impact on patient access to affordable generic drugs. (patexia.com)
The intersection of patents and generic drug approvals is a dynamic space, where innovation, legal disputes, and public health considerations intersect. (patexia.com)
In the case of publicly developed drugs, under the Bayh-Dole Act of 1980 the government has so-called "march-in rights" to effectively extinguish such patents if the drug is not being distributed on "reasonable terms. (prospect.org)
It regulates both "brand-name" and generic drugs, which are the chemical equivalent of brand-name drugs but with expired patents. (heritage.org)

News reports indicate that generic versions of the EpiPen have been subject to additional questioning by the FDA and have yet to be approved. (wfdd.org)
You've no doubt seen them in the grocery store - typically drab-looking packages on the bottom shelf containing lower-priced generic versions of popular brand-name products. (harvard.edu)
They found that before the generic versions became available, about one in 10 people taking the blood pressure drugs had to go to the emergency room or be hospitalized each month. (harvard.edu)
A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. (drugs.com)
Introducing competing "biosimilar" versions of complex biologic drugs used to treat illnesses such as cancer and rheumatoid arthritis could cut spending on biologics in the United States by $44 billion over the next decade, according to new analysis from the RAND Corporation. (scienceblog.com)

A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. (drugs.com)
The National Institute on Drug Abuse also was crucial to the approval by forming a public-private partnership by designing and conducting the clinical trials required to determine that the intranasal formulation delivered naloxone as quickly and as effectively as an injection. (medscape.com)

The Mumbai-based company's product is the generic equivalent of Gilead Sciences' Vemlidy tablets, it added. (peppystores.com)
The company has an awful lot riding on this drug getting approved, particularly since it recently lost a court decision in mid-June over Tecfidera, the company's blockbuster multiple sclerosis drug. (biospace.com)
The drug brought in $3.3 billion in the U.S. in 2019 and the company's '514 patent won't expire until 2028. (biospace.com)

Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present. (fda.gov)

On January 27, 2022, the U.S. District Court for the District of Connecticut gave preliminary approval to a $420 million all-cash deal to settle claims from a class of investors over misrepresentations related to the value of Teva's generics drug business, which has been the subject of numerous investigations and lawsuits over far-reaching market allocation and price fixing practices. (schneiderwallace.com)
FDA is announcing the fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year (FY) 2022. (alston.com)

The GVK staffer wrote to global drug authorities raising doubts on clinical trials. (thehindu.com)
And in early December, Biogen presented full data on the drug at the 12th Clinical Trials on Alzheimer's Disease (CATD) conference held in San Diego. (biospace.com)
After extensive testing and clinical trials, the FDA must approve drugs for their safety and effectiveness. (heritage.org)
The approval was based on an analysis of data from 3 Japanese and 15 non-Japanese clinical trials that confirmed the efficacy of moxifloxacin therapy in patients with respiratory tract infections, dermatologic infections, and acute sinusitis . (medscape.com)

HHS Secretary Alex Azar praised Gottlieb's work, saying: "Scott's leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco, and youth e-cigarette use, chronic disease, and more. (ajmc.com)

Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long. (wfdd.org)
and (2) allocating the market by trading off customers to ensure that each of the manufacturers selling a particular generic drug had its "fair share" of the market as determined by order of entry. (schneiderwallace.com)
The developer has specified the US as an intended market for approval. (globaldata.com)
Through an acquisition, Pfizer owns half of the U.S. market for the drug, where it and Astellas share costs and profits. (prospect.org)
If you've got 20 generic companies sharing the market, the margins and volumes are very thin. (aao.org)
The global market for generic drugs should grow from $411.6 billion in 2020 to $650.3 billion by 2025, at compound annual growth rate (CAGR) of 9.6% for the period of 2020-2025. (bccresearch.com)
This report discusses the implications of all the above-mentioned trends in the context of the current size and growth of the market for generic drugs, both in global terms and broken down by the most important national markets. (bccresearch.com)
How is the global market for generic drugs evolving? (visiongain.com)
What are the major factors driving and restraining the generic drugs market dynamics? (visiongain.com)
Visiongain's study is intended for anyone requiring commercial analyses for the Generic Drugs Market. (visiongain.com)
Resistance limits the market life of antimicrobial drugs, while limited markets exist for agents only active against resistant pathogens. (cdc.gov)

Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). (fda.gov)
Experts say going by the current run rate, the FDA may clear at least 470 such products this year, a sharp uptick from 409 approvals in 2014. (indiatimes.com)
Analysts also note that the volume of filings for generic products by Indian companies has surged, adding to the existing logjam. (indiatimes.com)
Manufacturing problems at generic drug companies that can lead to compromised, substandard products that the federal inspectors ban from being imported or used to manufacture drugs in the United States. (aao.org)
The reason shortages happen is that, in most cases, there is little money in making these generic products. (aao.org)
Consequently, drug products containing bisulfites are prominently labeled as such. (msdmanuals.com)
15. History of grapefruit, pomelo or grapefruit products consumption and cannot stop at least 7 days before the study drug administration and until the completion of the study. (who.int)

We also help decipher why newly approved generics are still expensive, including ways patients can access affordable newly approved generics. (pharmacycheckerblog.com)
There are a few isolated cases - including studies on drugs to treat certain eye conditions - that do suggest that some generic drugs don't always produce the same response in patients. (harvard.edu)
A new paper published by the American College of Physicians makes several recommendations the group said are aimed at improving transparency around pharmacy benefit managers - called PBMs for short - in order to provide patients and physicians with "reliable and timely information" on drug pricing. (kffhealthnews.org)
The advocates' argument is that charging U.S. patients significantly more than patients in other high-income countries for the same drug is in fact unreasonable. (prospect.org)
That's roughly the same group targeted for treatment with infused COVID-19 antibody drugs, the standard of care in many countries for patients who don't yet require hospitalization. (ktvu.com)
Merck announced preliminary results last month showing its drug cut hospitalizations and deaths by half among patients with early COVID-19 symptoms. (ktvu.com)
Biogen said the data from a subset of patients that received a high enough dose of the drug had significant benefits on measures of cognition and function, including memory, orientation, and language, as well as benefits on activities of daily living. (biospace.com)
however, there are other KOLs we have spoken with who still expect approval (from a risk/reward and high unmet need perspective in Alzheimer's) and admit that any new disease-modifying drug is good news and will be tried in many Alzheimer's patients. (biospace.com)
Ensuring a fair system for drug pricing and coverage rules that balance the goods of individual patients with the needs of broader populations when resources are limited remains more important than ever," Tsou said. (medscape.com)
Commenting on the statement for Medscape Medical News, Ilana Katz Sand, MD, associate director of the Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center, New York City, noted that clinicians are already acutely aware of the effect high drug costs have on their patients' medical decisions. (medscape.com)
It's a terrible thing and it's happening to all patients," Katz Sand said, adding that the old credo of 'Yeah, the drug prices are high, but they are covered by insurance' is not a sustainable argument anymore. (medscape.com)
The approval was based in part on data from a phase 2 study showing that 73% of patients treated with anecortave acetate had stable or improved vision at 24 months compared with 47% of patients who did not receive the drug ( P = .035). (medscape.com)

But, the experts add, even more can be done to get generics on pharmacy shelves and keep drug prices coming down. (ushealthcarecosts.com)
I'm proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. (pharmacycheckerblog.com)
Of the 10 generic drugs available internationally, the prices are on average 85% lower than prices in the U.S. (pharmacycheckerblog.com)
A source for news and analysis about drug prices and safety, online pharmacies and personal drug importation, published on behalf of American consumers. (pharmacycheckerblog.com)
Get notified about new posts to stay informed about online pharmacies, personal drug importation, drug prices and safety. (pharmacycheckerblog.com)
Axios: Lower Drug Prices Would Obliterate Profits And Research? (kffhealthnews.org)
The secretive group, known as Citizens for Truth in Drug Pricing, has blanketed airwaves with radio advertisements and sponsored commentary that sharply criticizes drug companies for high prices. (kffhealthnews.org)
Sen. John Thune (R-S.D.), the Senate's No. 2 Republican, said Tuesday that it is unlikely the Senate will pass legislation to lower drug prices before the end of the year. (kffhealthnews.org)
Was President Trump's plan to reduce drug prices DOA? (mmm-online.com)
President Trump's blueprint to lower drug prices hasn't made it out of the brainstorm phase. (mmm-online.com)
Remember back in May when President Donald Trump announced his blueprint for cutting drug prices? (mmm-online.com)
The re-empowered Democrats have their own agenda for controlling drug prices. (mmm-online.com)
Proponents will point to the lower drug prices paid by the Veterans Administration and laud the discounts exacted by foreign healthcare programs such as Britain's NICE. (mmm-online.com)
Drug prices aren't fixed, with different insurance plans offering different pricing, deductibles, and co-pays. (medscape.com)

It doesn't require congressional approval. (prospect.org)
Because of the FDA commissioner's broad discretionary authority within existing law, there are a variety of administrative actions that Gottlieb may take without first seeking congressional approval. (heritage.org)

Merck and its partner Ridgeback Biotherapeutic have requested clearance for the drug with regulators around the world to treat adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. (ktvu.com)

This report provides you with the data to allow you to track and predict specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using a combination of machine learning and proprietary models. (globaldata.com)
The FDA approved a record 83 new generic drug applications out of India's publicly listed firms in the last six months of 2015, just as sanctions against the biggest of those firms were making headlines, according to FDA data compiled by Bloomberg. (livemint.com)
Data collectors drug use indicators. (who.int)
DSN: CC37.NHAMCS92.EMRGENCY (Emergency Department File) CC37.NHAMCS92.OPATIENT (Out-Patient Department File) ABSTRACT This report provides documentation for users of the 1992 National Hospital Ambulatory Medical Care Survey (NHAMCS) Micro-Data Tape for patient visits and drug mentions. (cdc.gov)

A recall of two lots of Brexafemme (ibrexafungerp) tablets by Scynexis due to potential for cross-contamination with a nonantibacterial beta-lactam drug substance. (acpinternist.org)
The manufacturer has not received any reports of foreign tablets in any bottles of betaxolol, but there are only minor differences in appearance between the drugs and inadvertent exposure to this controlled substance could result in significant risks to certain patient populations. (acpinternist.org)

But he stressed that the FDA pushes pending applications for drugs with no current generics to the front of the line and approved 580 generics in 2015, a record for the agency and 40 percent more than in 2014. (wfdd.org)

Indeed, past research has shown that most of the time, generics seem to perform the same as the brand-name drugs. (harvard.edu)
An inspection blitz on Indian drug factories that supply to the US helped push the broader index of Indian healthcare stocks down by as much as 20% earlier this year from its all-time high in 2015 after some top firms received warning letters for failing to meet the regulator's standards. (livemint.com)

We give a short overview of the safety of personal medicine imports from accredited international online pharmacies, and discuss brand versus generic quality across different countries. (pharmacycheckerblog.com)
We would like to give you an overview of vast array of generics portfolio. (tajgenerics.com)

And given the unusual close working relationship between the FDA and Biogen, we still believe that the FDA wants to approve this drug in early Alzheimer's. (biospace.com)

The EMA along with the European Commission, which handles approval of marketing materials, are approving generics and brand-name drugs in about a year on average, according to the EMA. (wfdd.org)
I think it would be the triumph of hope over experience to think that we could get it done before the end of the year, but there's a lot of interest in doing something on drug pricing," Thune told reporters on Tuesday. (kffhealthnews.org)
Some of the Indian drug makers have already seen faster approvals this year. (indiatimes.com)
Last year, researchers at Emory University decided to repurpose the drug as a potential COVID-19 treatment. (ktvu.com)
13. History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of the study. (who.int)

The criminal charges came as part of a larger investigation of the generics industry that has seen five companies reach agreements with the DOJ. (schneiderwallace.com)
Only drugs in development by companies are included in the model. (globaldata.com)
Financial instability at generic companies, which can lead them to abruptly cease operations. (aao.org)
The nature and structure of the generic drug industry is discussed, with profiles of the leading 20+ generic drug companies and an update on M&A activity. (bccresearch.com)
Smaller companies are getting more approvals as they take over production of the simple, low-margin generic pills the larger companies built their businesses on. (livemint.com)

But for the most part, generics appear to be just as good at treating conditions as the brand-name formulations, says Dr. Choudhry. (harvard.edu)

Fortunes of generic drug makers to a great extent hinges on their approval timelines. (indiatimes.com)

GlaxoSmithKline (GSK) on Tuesday announced plans to invest $97 million over 10 years "to improve research, development and access to AIDS drugs in Africa," Reuters reports. (news-medical.net)
Our Drug Interaction Checker provides rapid access to tens of thousands of interactions between brand and generic drugs, over-the-counter drugs, and supplements. (medscape.com)
Drug Access: Who Does What? (bvsalud.org)

Chemicals and Drugs3

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Phenomena and Processes1

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20186

ANDA8

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Insight2

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Prescription14

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Brand-name counterpart1

Recalls1

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20222

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