Generic approval. Medical search. Frequent questions

On 27 May 2021, Zydus Cadila received US Food and Drug Administration (FDA) approval to market fluphenazine hydrochloride tablets which is used to treat schizophrenia and other types of mental condition. (gabionline.net)
On 7 June 2021, Lupin Ltd received approval for emtricitabine and tenofovir disoproxil fumarate tablets which are used in combination with other antiretroviral agents for the treatment of HIV. (gabionline.net)

We are extremely pleased with the FDA's decision to approve Teva's ANDA for the first and only fully substitutable generic version of Mylan's branded EpiPen, the most widely used epinephrine auto injector on the market," said Robert F. Apple, President and Chief Executive Officer of Antares Pharma. (globenewswire.com)
Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Cymbalta®, duloxetine hydrochloride delayed-release capsules. (bionity.com)
Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Zolpidem Tartrate Tablets. (pipelinereview.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)
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)
PITTSBURGH, Nov. 17 /PRNewswire-FirstCall/ - Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Extended-release (ER) Capsules, 37.5 mg (base), 75 mg (base) and 150 mg (base). (swmpa.org)
HAYWARD, Calif., May 03, 2006 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Colestid(R) (Colestipol Hydrochloride for Oral Suspension USP) 5 g Packet and 5 g Scoopful. (amneal.com)
Approval of this ANDA, the first generic version of Colestid, validates our strategy to develop and market niche generic drugs for which there is a limited competitive environment," said Larry Hsu, Ph.D., IMPAX's president. (amneal.com)
This is our second ANDA approval this year," Dr. Hsu added. (amneal.com)
FDA met or exceeded all GDUFA review goals to date, including goals for original Abbreviated New Drug Applications (ANDAs), ANDA amendments, Prior Approval Supplements (PAS), and controlled correspondence. (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)
15th of March, 2022, the U.S. Food and Drug Administration approved the first generic of Symbicort, by Mylan Pharmaceuticals. (nckpharma.com)
Hikma expects healthy prospects for its US Advair generic in 2022, despite rival Teva recently receiving FDA approval for its own version. (citeline.com)

While Momenta Pharmaceuticals and Novartis' Sandoz generics unit already sell versions of the 20mg formulation, the approval of Mylan's 40mg competitor is key to taking market share from Teva as around 85% of patients have switched to the higher dose after FDA approval in 2014. (pharmaphorum.com)

The FDA's generic count doesn't include biosimilars, which are more complicated medicines to review. (wfdd.org)
Torrent expects US FDA's final approval for Allergan/Almirall's Aczone, a dapsone formulation for acne vulgaris, in February, even as it awaits regulatory clearance for manufacturing sites. (citeline.com)
As a result, FDA's generic drug program became increasingly under-resourced. (fda.gov)
The list - posted on the FDA's website May 17- includes dozens of both generic and brand-name companies that the agency said appear to have refused to give up samples of their product to generic companies seeking to make copies. (medscape.com)

Generic drugs approved by FDA have the same high quality and strength as brand-name drugs. (news-medical.net)
The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs. (news-medical.net)
The FDA approval of Mylan's Copaxone copy is particularly significant, as it is a 'complex generic' - a class of drugs for which the US regulator says it will aim to speed up approvals. (pharmaphorum.com)
FDA Commissioner Scott Gottlieb spelled out his intentions in a blog post published on Monday, saying the complex nature of some drugs - such as metered dose inhalers and some injectables - had become unfair barriers to generic approvals. (pharmaphorum.com)
Gottlieb even went as far as to identify Copaxone (glatiramer acetate) by name, and laid out how regulatory hurdles would be lowered for generic versions of complex drugs. (pharmaphorum.com)
Although Teva is known as the world's largest generics manufacturer, it also has a branded drugs business and Copaxone is its largest single source of revenue. (pharmaphorum.com)
Where are the generic alternatives to EpiPen and other expensive drugs that have lost patent protection? (wfdd.org)
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)
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)
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)
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)
Generics tend to cost less than brand-name drugs. (medicalnewstoday.com)
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)
Do generic drugs compromise on quality? (harvard.edu)
Are generic drugs really the same quality, or is it better to spend more for the name-brand version? (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)
Study authors said this might suggest performance differences between the brand-name and generic drugs. (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)
Indeed, past research has shown that most of the time, generics seem to perform the same as the brand-name drugs. (harvard.edu)
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)
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 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 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)
Generic drugs: A bargain or sticker shock? (ushealthcarecosts.com)
Generics usually cost less than brand-name drugs. (medicalnewstoday.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)
I'm proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. (pharmacycheckerblog.com)
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)
The brand in the U.S. is cheaper than the U.S. generic for 3 of the 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)
Of those, 14 of the brand-name drugs available internationally cost on average 73% less than the U.S. generic versions . (pharmacycheckerblog.com)
Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. (drugs.com)
About 25 percent of all generic drugs that FDA has ever approved were approved in the past four years. (fda.gov)
At the same time, GDUFA helps assure the quality of generic drugs. (fda.gov)
Patient confidence that generic drugs will work the same as brand products, and can be freely substituted, is the foundation for trillions of dollars in savings that generics produce for the healthcare system. (fda.gov)
According to the QuintilesIMS Institute, generic drugs now account for 89 percent of prescriptions dispensed in the United States, and saved the U.S. healthcare system $1.46 trillion from 2005 to 2015. (fda.gov)
Over the last several decades, the generic industry, the number of generic drug applications, and the number of foreign facilities making generic drugs grew substantially. (fda.gov)
As noted previously, approximately 25 percent of all currently approved generic drugs were approved over the past four years. (fda.gov)
Celgene, in a statement emailed to Medscape Medical News , said it had "sold and will sell our groundbreaking products to generic manufacturers for the purposes of bioequivalence testing, subject to reasonable safety-related and business requirements" and noted that generic versions of its drugs, including Revlimid, have been licensed for sale and will enter the market in coming years. (medscape.com)
Overview of Generic Drugs and Drug Naming Medications are drugs used therapeutically (that is, to treat medical conditions). (msdmanuals.com)
New forms include new dosage forms or strengths of an existing brand-name drug product and any other modified form that is developed, as well as new generic drugs. (msdmanuals.com)
Drug information included within Medscape Drugs & Diseases is based on FDA approvals. (medscape.com)
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)
This Viewpoint discusses how limited-supply agreements (introduction of generic products in reduced volumes) might thwart efforts to negotiate lower prices on prescription drugs in the US. (bvsalud.org)
Identify precisely all the drugs and chemicals used, including generic names, dose and form of administration and cite in the article the approval number from the Ethics in Research Committee (ERC). (bvsalud.org)

Lupin's tablets will join other generic versions of the product on the US market, which was opened for Teva Pharmaceutical's Truvada generic in 2020 [1]. (gabionline.net)
Gilead's Truvada will face generics competition in 2020 [www.gabionline.net]. (gabionline.net)

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)
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)
However, price changes are on the horizon after a recent NBC News article noted the FDA has approved the first generic epinephrine auto-injector and issued new guidance for generic copies. (healthcarepackaging.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)
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)
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)
Our goal with this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. (gabionline.net)
Sign up today for the weekly briefing on the latest developments in generic and biosimilar medicines! (gabionline.net)
GDUFA has expanded access to affordable generic medicines. (fda.gov)
Expanded Consumer Access to Quality, Affordable Generic Medicines. (fda.gov)
According to the generic drug industry lobbying arm - the Association for Accessible Medicines (AAM) - 27 products on the list had no REMS with ETASU. (medscape.com)

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)
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)

Lupin on Wednesday stated its American subsidiary has obtained an approval from the US well being regulator to market a generic product used for therapy of pores and skin points. (secularnewsdaily.com)
New Jersey-based Novel Laboratories Inc has obtained the approval from the US Meals and Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, Lupin stated in a press release. (secularnewsdaily.com)

Without the samples, generic manufacturers can't conduct bioequivalence testing and apply to the agency for approval, said commissioner Scott Gottlieb, MD, in a statement . (medscape.com)

We and our partner Teva worked diligently together to obtain the approval of this very complex drug/device rescue pen combination product utilizing our VIBEX auto injector platform and we look forward to Teva making it commercially available to patients. (globenewswire.com)
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)
The U.S. Food and Drug Administration today approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults. (news-medical.net)
Teva has been granted a 180-day period of generic drug exclusivity, which means that FDA cannot approve another generic version of escitalopram tablets before the end of that period. (news-medical.net)
Vitruvias Therapeutics and Sunny Pharmtech have received approval from the Food and Drug Administration (FDA) to market a generic equivalent to Amicar ( Akorn ), an inhibitor of fibrinolysis. (empr.com)
A WHO approval indicates that a drug meets international safety, efficacy and manufacturing quality standards. (biospace.com)
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)
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)
The FDA is confident that the overall trend in actions on generic drug applications will be one of continuing improvement," Baumgartner said. (wfdd.org)
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)
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)
This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. (nckpharma.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)
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)
A generic drug is an exact copy of the active drug in a brand-name medication. (medicalnewstoday.com)
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)
But, the experts add, even more can be done to get generics on pharmacy shelves and keep drug prices coming down. (ushealthcarecosts.com)
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)
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)
However, the intersection of patents and generic drug approvals can be a complex and challenging landscape. (patexia.com)
To obtain FDA approval, generic drug manufacturers must demonstrate bioequivalence to the reference listed drug (RLD) and show that their product is safe, effective, and interchangeable with the brand-name drug. (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 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)
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. (amneal.com)
Thank you for the opportunity to be here today to discuss the first reauthorization of the Generic Drug User Fee Amendments (GDUFA), also referred to as GDUFA II, as well as the first reauthorization of the Biosimilar User Fee Act (BsUFA), also referred to as BsUFA II. (fda.gov)
Under these user fee programs FDA has dramatically reduced the review time for new products, without compromising the Agency's high standards for demonstration of safety, efficacy, and quality of new drug products prior to approval. (fda.gov)
Historically, the generic drug program has been a great success. (fda.gov)
The generic drug industry has grown from modest beginnings into a major force in healthcare. (fda.gov)
After much negotiation, FDA and the generic drug industry, in consultation with other stakeholders, developed a proposal for a generic drug user fee program and submitted it to Congress. (fda.gov)
Most "first generic" ANDAs cannot lawfully be filed until a specific date, either four or five years after the innovator drug was approved. (fda.gov)
For example, last year we had timely approvals of nine generic versions of Crestor, a cholesterol drug with approximately $5 billion in annual sales. (fda.gov)
The US Food and Drug Administration (FDA) has followed through on its promise to publicly name companies it says may be gaming drug laws to block generic competition. (medscape.com)
The FDA said it has heard about many different ways that brand-name manufacturers have blocked access to samples, including making it hard for generic companies to purchase them at a fair value and in the open marketplace, or by putting restrictions in contracts with distributors, wholesalers, or specialty pharmacies that limit those middlemen's ability to sell samples to generic drug developers. (medscape.com)
Even in cases where a REMS with ETASU program exists, "generic drug developers should be able to secure samples of the product," said Gottlieb. (medscape.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)
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)
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)
Findings: On the 10 GLP-1 receptor agonists included in the cohort, drug manufacturers listed with the FDA a median of 19.5 patents (IQR, 9.0-25.8) per product, including a median of 17 patents (IQR, 8.3-22.8) filed before FDA approval and 1.5 (IQR, 0-2.8) filed after FDA approval. (bvsalud.org)
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)
drug name (preferably generic), has a population of 1.2 million people. (who.int)

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. (biospace.com)

This update covers the approval of an oral medication to reduce the risk of stroke and embolism in atrial fibrillation and the first generic version of esomeprazole. (acpinternist.org)
The generic version will be dispensed with a medication guide mentioning the risk of stomach problems, including severe diarrhea, and that multiple daily doses of proton- pump inhibitors for a long period may cause an increased risk of bone fractures. (acpinternist.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)
Generic makers need 1500 to 5000 units of a medication to conduct proper bioequivalence testing, said Gottlieb. (medscape.com)

Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities. (swmpa.org)
FDA expedites the review of potential "first generic" ANDAs because they can open the market to generic competition for the first time. (fda.gov)
We worked hard to review ANDAs for first generics even faster, expediting their review like an express line at the supermarket. (fda.gov)

Approval of China's first rituximab biosimilar under new pathway gives developers much-needed boost and an opening to the international market for made-in-China biosimilars helped by favorable regulatory policy changes at home. (citeline.com)
1. GaBI Online - Generics and Biosimilars Initiative. (gabionline.net)

Henlius says it can now pursue a "differentiated strategy" for its HLX01 rituximab biosimilar in China, after winning approval for a key rheumatoid arthritis indication from the NMPA. (citeline.com)

Teva Pharmaceutical Industries/IVAX Pharmaceuticals gained FDA approval to market generic escitalopram in 5 milligram, 10 mg, and 20 mg strengths. (news-medical.net)
Adamis Pharmaceuticals reported a similar rejection from the FDA for its EpiPen generic in June. (wfdd.org)
The generic EpiPen competitor will be made by Israeli generic manufacturer Teva Pharmaceuticals, and won't be sold under the same name. (healthcarepackaging.com)
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers. (pipelinereview.com)
The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals, Inc. (nckpharma.com)
IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. (amneal.com)
Some companies known as being primarily generic manufacturers were also on the list, including Ranbaxy/Sun, Mylan Pharmaceuticals, and Teva Pharmaceuticals. (medscape.com)

Métodos: Estudio prospectivo, descriptivo, aleatorizado, conducido en el Hospital de Pediatría Juan P. Garrahan de la Ciudad Autónoma de Buenos Aires en el período entre el 1 de setiembre de 2018 y el 31 de marzo de 2019. (bvsalud.org)

The Mumbai-based company's product is the generic equivalent of Gilead Sciences' Vemlidy tablets, it added. (peppystores.com)
These are a generic equivalent of Gilead Sciences, Inc's Truvada tablets. (gabionline.net)

To our knowledge, there are no restrictions preventing generic manufacturers from accessing these Novartis products and we have communicated that to generics companies that have contacted Novartis with similar requests. (medscape.com)

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)

The timing could not have been worse for Teva, which is struggling to pay off debts of around $35 billion it accrued when buying Allergan's generics business last year. (pharmaphorum.com)
Mylan's Copaxone (glatiramer) generic hits Teva where it hurts as it has been approved at both the daily 20mg dose, or the 40mg thrice weekly dose that most patients have switched to. (pharmaphorum.com)

Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long. (wfdd.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)
On Monday, three members of the House Committee on Energy and Commerce wrote a similar letter to the FDA, seeking information about the EpiPen generic applications it has received and how they've been prioritized. (wfdd.org)
Approval of the first generic competitor to Mylan's EpiPen will spark downward pressure on the high-scrutinized price of the original. (healthcarepackaging.com)

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)

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

No generic firm has successfully challenged patents on GLP-1 receptor agonists to gain FDA approval. (bvsalud.org)

The first generic version of esomeprazole (Nexium) to treat gastroesophageal reflux disease in adults and children ages 1 and older, as well as to reduce the risk of gastric ulcers associated with use of NSAIDs, to treat Helicobacter pylori along with certain antibiotics, and to treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome. (acpinternist.org)
Lopinavir/Ritonavir Tablets are the generic version of Abbott Laboratories' Kaletra(R) Tablets, the brand marketed in the U.S. and Europe, and Alluvia Tablets, the brand marketed in the developing world. (biospace.com)
Venlafaxine HCl ER Capsules, indicated for the treatment of major depressive disorder and generalized anxiety disorder, are the generic version of Wyeth Pharmaceutical Inc.'s Effexor XR(R) Capsules. (swmpa.org)

These generic duloxetine hydrochloride delayed-release capsules, 20 mg (base), 30 mg (base), and 60 mg (base) are indicated in the treatment of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD) and Diabetic Peripheral Neuropathic Pain (DPNP). (bionity.com)

Conclusions and Relevance: Patent and regulatory reform is needed to ensure timely generic entry of GLP-1 receptor agonists to the market. (bvsalud.org)

PITTSBURGH, Feb. 25 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received the first and only World Health Organization (WHO) approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. (biospace.com)

The primary outcome was the duration of expected protection from generic competition, defined as the time elapsed from FDA approval until expiration of the last-to-expire patent or regulatory exclusivity. (bvsalud.org)

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)
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)

Meanwhile, Hikma CEO Siggi Olafsson also outlined expectations for generic competition on icosapent amid ongoing API shortages. (citeline.com)

India authorizes molnupiravir for restricted emergency use in COVID-19, marking the arrival of around a dozen "affordable" generics of Merck & Co. and Ridgeback Biotherapeutics' oral antiviral. (citeline.com)

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)
In addition, manufacturers have filed numerous applications for generic versions of its products, said the company. (medscape.com)
The MMG Development Team posted pilot test-ready versions of the Generic v2 and Hepatitis MMGs and their artifacts to the Draft MMG Web Site. (cdc.gov)

Management signals cost edge for generic Advair as it awaits further word following a FDA establishment inspection report at its Indian site, while a Plan B is being initiated for generic Abraxane. (citeline.com)

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)

We also help decipher why newly approved generics are still expensive, including ways patients can access affordable newly approved generics. (pharmacycheckerblog.com)

The approval is also significant for a host of other 'complex generic' products in the US, with the FDA announcing measures to reduce barriers to their approval. (pharmaphorum.com)
The proposed rule would also permit generic label approval for products that receive voluntary FSIS inspection (e.g., exotic species under 9 CFR part 352) on the same basis as amenable meat, poultry, and egg products. (usda.gov)

Manufacturers augmented patent protection with a median of 2 regulatory exclusivities (IQR, 0-3) obtained at approval and 1 (IQR, 0.3-4.3) added after approval. (bvsalud.org)
The median total duration of expected protection after FDA approval, when accounting for both preapproval and postapproval patents and regulatory exclusivities, was 18.3 years (IQR, 16.0-19.4). (bvsalud.org)

In addition, generic medications can play an important role in reducing health care costs and improving access to care, he says. (harvard.edu)

A standardized, structured questionnaire collected information on demographic and socioeconomic measures, avian influenza information sources and knowledge of appropriate preventive measures, poultry and animal handling, food and generic hygiene, and human influenza knowledge and treatment seeking. (cdc.gov)

The FDA has approved more generics in the past few years, but a flood of applications has added to the problem. (wfdd.org)

FSIS is proposing to amend its inspection regulations pertaining to the generic approval of meat, poultry, and egg product labels. (usda.gov)

Record Increase in Approvals. (fda.gov)

We expect to receive OMB PRA approval in early 2019. (cdc.gov)

The Message Validation, Processing, and Provisioning System (MVPS) developer delivered the revised message processing functionality for Generic v2, STD, and Hepatitis to CDC on 7/2/15. (cdc.gov)

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)

This was the most approvals ever in one year. (fda.gov)

Under FSIS regulations, certain categories of labels must be submitted to FSIS for review and approval before use. (usda.gov)
Ethical approval was provided by the Institutional Review Board, Ministry of Public Health, Afghanistan. (cdc.gov)

This approval means patients living with severe, sometimes life-threatening allergic reactions, (anaphylaxis), who require immediate access to life-sparing epinephrine should have access to a generic alternative. (globenewswire.com)

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)

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