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  • ANDA
  • While the petition does raise, among other things, the issue of 3-year exclusivity eligibility and the effects on generics, that petition is more about the scope of 3-year exclusivity than ANDA labeling carve-outs. (fdalawblog.net)
  • Generic drugs are those approved under the 505(j) pathway of the Federal Food, Drug and Cosmetic Act (FD&C Act) and submitted to the agency through an abbreviated new drug approval (ANDA) application. (raps.org)
  • Once an existing drug's marketing and patent exclusivity has expired, generic drug manufacturers can file an ANDA with FDA to approve their drug based on safety and efficacy data from the original drug their application references, also known as the reference-listed drug (RLD). (raps.org)
  • In general, most drugs in the US are approved in one of two ways: Either as a new drug product (such as a new chemical entity never before approved, or at a never-before-approved dose) through a new drug application (NDA), or as an exact copy of an already-approved drug through the abbreviated new drug application (ANDA) pathway. (raps.org)
  • The ANDA pathway, otherwise known as the 505(j) pathway, allows for the approval of drugs that are generic-a term never actually used in the statute or regulations-versions of an already-approved drug. (raps.org)
  • MannKind
  • For drugs with available options that don't carry such warnings, such as MannKind 's inhalable insulin, Afrezza, for treatment of diabetes, a black box can make make marketing the drug extremely difficult. (foxbusiness.com)
  • The U.S. Food and Drug Administration's (FDA) delay in completing its review of MannKind Corp .'s ultra rapid-acting insulin therapy, called Afrezza , by the expected action date of January 16 has added to uncertainty over the commercial prospects of this experimental inhaled insulin. (cbsnews.com)
  • Chief financial officer Matt Pfeffer stressed in a phone interview with me on Monday that Mann's comments on PFTs represented his opinion as a private investor -- and were not representative of the company's position (as MannKind had not yet resolved discussions with the FDA over the specifics for labeling). (cbsnews.com)
  • risks
  • Allowing juries to make determinations about drug risks, Mr. Rogers said, would cause "mass confusion. (nytimes.com)
  • The drug industry had warned that the new labeling might pose risks to manufacturers facing litigation from plaintiffs claiming they weren't warned about side effects of medicines, because not all risks would be equally emphasized in the new format. (beasleyallen.com)
  • Drug makers will now be allowed to use the sometimes-shorter list of risks from the highlights section as a basis for their ads. (beasleyallen.com)
  • While FDA regulations allow brand name manufacturers to independently update their labels if they identify new risks or side-effects, generic drugs can only adopt the approved changes made by the brand-name. (votesmart.org)
  • We must ensure that all manufacturers have the ability to update their labels to reflect newly discovered risks and side-effects of their products. (votesmart.org)
  • The Food and Drug Administration (FDA) has notified health care professionals that new risks have been added to the drug label for the asthma drug Xolair (omalizumab). (acc.org)
  • The results indicate an urgent need for more effective methods of informing physicians about the level of evidence supporting off-label drug use""especially for common off-label uses that are ineffective or carry unacceptable risks of harm. (redorbit.com)
  • Rule
  • referred to as the " Pregnancy and Lactation Labeling Rule " (PLLR or final rule). (fda.gov)
  • The PLLR requires changes to the content and format for information presented in prescription drug labeling in the Physician Labeling Rule (PLR) format to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children. (fda.gov)
  • OTC drug products are not affected by the final rule. (fda.gov)
  • The new label rule, which has been in the works for several years, reorganizes the inserts into a more easy-to-follow, standardized format. (beasleyallen.com)
  • The industry has closely monitored the development of the new labeling rule. (beasleyallen.com)
  • The FDA said that in response to the companies' complaint, the rule includes a statement that the content of labels should pre-empt state liability laws. (beasleyallen.com)
  • revise
  • PHILADELPHIA -- American Home Products Corp.'s Wyeth-Ayerst Laboratories unit and Interneuron Pharmaceuticals Inc. will revise the labeling for their obesity drug, Redux, to show a higher risk of a potentially fatal lung disorder. (wsj.com)
  • Today Congressman Chris Van Hollen (D-MD) and Congressman Bruce Braley (D-IA) announced the introduction of the Patient Safety and Drug Labeling Improvement Act, legislation to ensure that all prescription drug manufacturers can revise their labels to provide accurate, up-to-date warnings to consumers. (votesmart.org)
  • The Patient Safety and Drug Labeling Improvement Act resolves this situation by authorizing generics to revise their labels using the same processes that are currently available to brand-name manufacturers. (votesmart.org)
  • patients
  • Belknap and his colleagues concluded that 5α-reductase inhibitors are not only linked with erectile dysfunction while patients are using the drug, but that these symptoms persist even after stopping usage-a condition referred to as Persistent Erectile Dysfunction (PED). (healthline.com)
  • They quoted Dr. Michael Irwig, an endocrinologist at George Washington University as saying "What we do want is for patients and doctors alike to understand the potential risk of persistent problems that may not, in fact, be reversible when you stop this drug. (healthline.com)
  • For example, a quick comparison of drug labels from Harvoni, by Gilead Sciences ,and its would-be competitor for hepatitis C Virus patients, Viekira Pak from AbbVie , would have provided hints that it had little chance of displacing Harvoni's dominance in the space. (foxbusiness.com)
  • There is an effort to make labeling information easier for patients to understand. (lifescienceleader.com)
  • The labeling information for both Avelox (moxifloxacin) and Cipro (ciprofloxacin) already contained a warning and precaution information regarding cases of sensory or sensorimotor axonal polyneuropathy in patients receiving fluoroquinolones many years before the FDA issued its Drug Safety Communication in August 2013. (nbcconnecticut.com)
  • Information provided to patients is thought to influence placebo and drug effects. (sciencemag.org)
  • There are reasons doctors would resort to off-label uses, namely in the cases of patients with rare or terminal illnesses. (healthline.com)
  • But patients and doctors alike have complained that the inserts are confusing, and there is evidence that physicians don't always follow the labels' recommendations. (beasleyallen.com)
  • One study, published last year and based on patient prescription databases, found that even when drug labels had very strong "black box" warnings and recommended tests for patients starting the medicine, those tests were done only about half the time. (beasleyallen.com)
  • Patients who don't get drug labels from their pharmacist will eventually be able to look up the documents in a new DailyMed online library being developed by the government. (beasleyallen.com)
  • In a medical environment, overlooking something very small could have a major impact on the health of patients, which is why medical labels are so important. (labelvalue.com)
  • American patients deserve to have faith in the safety of their prescription drugs, and these types of errors are costing billions of dollars to our health care system. (votesmart.org)
  • New safety studies show that patients taking the drug are at a slightly higher risk for problems with the heart and blood vessels supplying the brain than patients not taking Xolair. (acc.org)
  • Although the studies showed no increased rates of cancer in patients taking the drug, the FDA states that the potential risk of cancer cannot be ruled out. (acc.org)
  • At the time of the study there was an FDA-advisory specifically urging caution regarding the off-label use of quetiapine in patients with dementia. (redorbit.com)
  • The fear is that such marketing would encourage the widespread use of drugs in settings where their efficacy and safety has not been rigorously tested, exposing patients to uncertain benefits and possible adverse effects. (medpagetoday.com)
  • The commonest goal (85% of cases) was expansion of drug use to unapproved diseases (for example, gabapentin, which is approved for the treatment of specific types of epilepsy, was allegedly promoted as a therapy for patients with psychiatric diseases such as depression). (medpagetoday.com)
  • makers
  • However, opponents fear increasing the influence drug and device makers have over the doctor-patient relationship could do more harm than good when companies are contractually obligated to reap profits for their shareholders. (healthline.com)
  • Product-liability lawsuits, such as the high-profile cases brought against Merck & Co. over its withdrawn painkiller Vioxx, have become a huge problem for drug makers. (beasleyallen.com)
  • The new label layout will also affect advertising, because the string of safety warnings that drug makers must include in print and broadcast ads is based on what's in the medicine's label. (beasleyallen.com)
  • clinical
  • If there was meaningful assessment of persistent sexual dysfunction in humans during the clinical development of the these drugs, this does not appear to have been reported in the medical literature, the FPI, or other publicly accessible sources. (healthline.com)
  • Beyond the first page, you can find more details about side effects in the 'adverse reactions' section, even data from the 'clinical studies' that led to the drug's approval. (foxbusiness.com)
  • Further, the Summit explored the existing guidance, and surrounding interpretation, on the legality of dissemination of various clinical and scientific documents that contain off-label uses. (nccn.org)
  • Despite an increased use of patient-reported outcomes (PROs) in oncology clinical trials, integrating the patient perspective into drug approval decisions and documentation has been challenging. (ahdbonline.com)
  • Second, because stakeholders do not always have access to data from early-stage clinical trials and do not contribute to the target drug's profile in early development, researchers are often unable to address the most important question in building a measurement strategy: What do we want to say about our drug? (ahdbonline.com)
  • Warnings
  • The FDA puts 'black box' warnings only on drugs that have special problems that could lead to serious injury or death. (foxbusiness.com)
  • The US Food and Drug Administration's (FDA) recent proposal to overhaul the manner in which generic drug manufacturers may update the safety warnings on their labels may be receiving warm praise from some legislators and industry watchers, but it might not be legal, say several legal experts. (raps.org)
  • The Court ruled that federal law precludes generics from independently changing their labels and therefore they cannot be held liable for failing to add or strengthen the warnings on their products. (votesmart.org)
  • doses
  • An important part of the (drug) approval process is the creation of the 'drug label,' a detailed report that specifies the exact diseases and patient groups in which the drug can be used, and the approved doses of the drug. (medpagetoday.com)
  • The other goals were expansion to unapproved disease subtypes (for example, some antidepressant drugs approved for adults were allegedly promoted to pediatricians for use in children) and expansion to unapproved drug dosing strategies, typically higher doses. (medpagetoday.com)
  • efficacy
  • The efficacy of open-label placebo was superior to that of no treatment. (sciencemag.org)
  • To review important regulatory and measurement terminology, and to provide oncology outcomes researchers and those involved with building oncology programs with tools to plan PRO data collection, particularly in relation to drug efficacy claims for drug labeling in the United States. (ahdbonline.com)
  • As for any drugs, the US Food and Drug Administration (FDA) is asked to consider the regulatory approval of cancer drugs based on "substantial evidence" of efficacy from adequate and well-controlled investigations. (ahdbonline.com)
  • 1 Historically, the efficacy of oncology drugs has been assessed based on objective tumor response rates, overall survival, time to tumor progression, disease-free survival, and progression-free survival. (ahdbonline.com)
  • Food
  • They're strictly regulated by the Food and Drug Administration and provide plenty of useful information savvy healthcare investors use to evaluate a company's products. (foxbusiness.com)
  • In 2013, after mounting complaints about adverse reactions, the Food and Drug Administration sent out a safety communication about fluoroquinolones warning that serious nerve damage could occur soon after taking them and could be permanent. (nbcconnecticut.com)
  • Contributing to the fall-off were analysts reports reining in sales projections for GSK's top-selling asthma product, Advair (salmeterol plus fluticasone) as a result of the action by the US Food and Drug Administration (FDA). (pharmatimes.com)
  • The surgeon who performed the procedure was using the device " off-label ," or for something not approved by the Food and Drug Administration (FDA). (healthline.com)
  • According to the U.S. Food and Drug Administration (FDA), knowing how to make use of over-the-counter (OTC) drug labels can help you protect yourself and your family from harm. (rochester.edu)
  • The Food and Drug Administration is investigating and in the meantime, has issued the following statement: "At this time, we do not have any indication that the counterfeit Avastin has reached the ophthalmic supply chain. (asrs.org)
  • Under federal law, generic drug manufacturers are required to use the same label approved by the Food and Drug Administration (FDA) for their brand-name equivalents. (votesmart.org)
  • adverse
  • The practice is suspected to be a factor of preventable adverse drug events, the authors write in their study background. (mcgill.ca)
  • 1 The appropriateness of such prescribing is uncertain, and a high rate of adverse drug reactions has been observed in children prescribed such drugs. (bmj.com)
  • data
  • Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women. (fda.gov)
  • These agents are among many drugs prescribed to children of any age with restricted or no pediatric data to support labeling. (lww.com)
  • Another challenge is the introduction of new labeling technologies for data tracking that differ from traditional bar codes. (lifescienceleader.com)
  • Some drug manufacturers have made use of digital and laser printing for labeling, allowing them to change labels accurately, quickly, and on the fly, while keeping all the required data for track, trace, and control. (lifescienceleader.com)
  • Instead of conducting new trials, they are required to submit data, such as bioequivalence data, showing that their drugs are for all intents and purposes identical to the RLD. (raps.org)
  • lawsuits
  • WASHINGTON - In a major setback for business groups that had hoped to build a barrier against injury lawsuits seeking billions of dollars, the Supreme Court on Wednesday said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators. (nytimes.com)
  • preventable
  • The Institute of Medicine estimates that each year at least 1.5 million preventable drug errors occur in American health care facilities, adding an average of $5,000 to the cost of a hospital admission where an error occurs. (votesmart.org)
  • important
  • Researchers say what is important is that those interested in taking these drugs are getting all the facts about them. (healthline.com)
  • This is an especially important consideration for biotech drugs and sterile liquids. (lifescienceleader.com)
  • But this last example notwithstanding, the most important physical requirement for generic drugs is that they be shown to be bioequivalent (BE) to the reference-listed drug (RLD) (i.e. the originally approved product). (raps.org)
  • It will have the date when the drug won FDA approval, an important piece of information for doctors who are often more comfortable with medicines that have been on the market for several years. (beasleyallen.com)
  • What would you do if you couldn't read important drug information on prescription bottles or package inserts? (afb.org)
  • However, knowledge about FDA labeling can be important, because FDA approval of a drug for a specific indication indicates a clear threshold of evidence supporting that use," Donna Chen, MD, Assistant Professor of Biomedical Ethics, Public Health Sciences, and Psychiatry at the University of Virginia is quoted as saying. (redorbit.com)
  • There's an important paper in PLoS Medicine, ' Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints . (medpagetoday.com)
  • 1,2 These end points, on which drug approval decisions are made, are still important today. (ahdbonline.com)
  • primarily used to treat
  • Researchers investigated 5α-reductase inhibitors, a class of drug primarily used to treat two conditions in men: androgenetic alopecia (male pattern hair loss) and benign prostatic hyperplasia (BPH), otherwise known as an enlarged prostate. (healthline.com)
  • approval
  • With the recent litigation surrounding FDA's approval of ANDAs for generic versions of PRECEDEX (dexmedetomidine HCl) Injection - which litigation has now moved on to Motions for Summary Judgment (see our updates here for the latest briefs) - we've had renewed interest in (and requests to update) our popular Generic Drug Labeling Carve-Out Scorecard (a.k.a. the Labeling Carve-Out Citizen Petition Scorecard). (fdalawblog.net)
  • If approved by FDA, the drugs are required to contain the exact same labeling with respect to the claim for which they obtained approval. (raps.org)
  • Relevant portions of the proposed label are reproduced below adjacent to a representative claim (claim 1) of the '610 patent, based on which approval for Fanapt® was obtained. (ipwatchdog.com)
  • Getting FDA approval for a drug - for labeled uses - requires a large investment, in both time and money. (healthline.com)
  • Our research shows that some off-label prescribing might be driven by mistaken beliefs about FDA approval and the level of evidence supporting off-label drug use," G. Caleb Alexander, MD, MS, Assistant Professor of Medicine at the University of Chicago Medical Center and corresponding author of the research is quoted as saying. (redorbit.com)
  • generic drug
  • But we found a few minutes to finally draft this post and make a permanent home for the Generic Drug Labeling Carve-Out Scorecard. (fdalawblog.net)
  • For example, if the RLD contains a warning that the drug could cause a heart attack, the generic drug would be required to list that side effect as well. (raps.org)
  • Alright, Start From the Beginning: What's a Generic Drug? (raps.org)
  • caution
  • Nonetheless, given long-term safety issues with the use of inhaled insulin in smokers or those diabetics with chronic obstructive pulmonary diseases -- including cancer risk or the diffusing capacity of carbon monoxide -- the Afrezza labeling will likely mandate [at worst] a black box labeling or [at best] caution against use in certain subsets of diabetics. (cbsnews.com)
  • practice
  • This practice is known as "off-label. (healthline.com)
  • The introduction and utilization of many innovative drugs and biologics in oncology practice, combined with their significant expense, has focused the attention of payors and other involved constituencies on processes and programs that facilitate the appropriate, effective, and efficient use of such agents. (nccn.org)
  • However
  • However, this labeling paradigm does not work both ways. (raps.org)
  • However, others said that Advair has been growing fast despite a black box warning pointing out the risk of more severe breakthrough attacks, which were uncovered in the SMART study of the drug. (pharmatimes.com)
  • However, because drugs' manufacturers stand to benefit financially from off-label use through increased drugs sales, the FDA prohibits them from directly promoting unapproved uses. (medpagetoday.com)
  • researchers
  • For a drug like finasteride, which has existed for over two decades and is estimated to be prescribed to 2.6 million men annually, researchers say that clear and accurate information about its relationship to sexual dysfunction should be more available. (healthline.com)
  • Journalists, especially, should be aware of the drug marketing practices the researchers found. (medpagetoday.com)
  • To overcome these challenges, researchers can systematically develop an end point model to facilitate communication among drug development stakeholders using a common language and to link the building blocks of a PRO measurement strategy, including claims, concepts, questionnaires, and end points. (ahdbonline.com)
  • participants
  • When participants were given placebo labeled as (i) placebo, (ii) Maxalt or placebo, and (iii) Maxalt, the placebo effect increased progressively. (sciencemag.org)
  • healthcare
  • When drugs are approved for prescription only, it's because the healthcare provider needs to monitor the patient. (lifescienceleader.com)
  • If you read a medicine label and still have questions, ask your healthcare provider, nurse, pharmacist, or other healthcare professional for advice. (rochester.edu)
  • Healthcare professionals should refer to the drug labels for the latest recommendations on prescribing statins. (fda.gov)
  • consumers
  • A recent study from Northwestern University has highlighted the need for more information about certain popular drugs targeted at male consumers that inadvertently cause erectile dysfunction and other side effects. (healthline.com)
  • Whether individual consumers get copies of drug labels often depends on if the drug they get comes in its original packaging. (beasleyallen.com)
  • As a result, consumers harmed by generic drugs with insufficient labels have no legal remedy, whereas consumers harmed by brand-name drugs do. (votesmart.org)
  • Consumers have the right to know the truth about the safety of drugs they are taking -- both brand and generic. (votesmart.org)
  • The Patient Safety and Drug Labeling Improvement Act is supported by AARP, Alliance for Justice, Consumer Action, Consumer Federation of America, Consumers Union, Consumer Watchdog, National Association of Consumer Advocates, and US PIRG. (votesmart.org)
  • It was conducted as part of AFB's Rx Label Enable Campaign , an initiative to ensure that people with vision loss have access to the vital information available to all consumers via prescription labeling and related documentation. (afb.org)
  • Payer-related practices (for example, discussions with prescribers about ways to ensure insurance reimbursement for off-label prescriptions) and consumer-related practices (most commonly, the review of confidential patient charts to identify consumers who could be off-label users) were also alleged. (medpagetoday.com)
  • risk
  • The Avelox and Cipro labels were updated in 2004 to warn of this risk. (nbcconnecticut.com)
  • Mandated pulmonary function tests (PFT) and/or any potential mention of the risk of cancer (proven or not) in the label could be deal breakers for the drug. (cbsnews.com)
  • breastfed infant
  • The Nursing mothers subsection was renamed, the Lactation subsection (8.2), and provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant. (fda.gov)
  • occur
  • This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent,' a spokesperson for the FDA wrote in an email to the NBC Connecticut Troubleshooters. (nbcconnecticut.com)
  • A study by other investigators published in 2006 indicated that approximately 21 percent of drug uses in the United States occur for off-label purposes, with 73 percent of those cases lacking scientific evidence of the drug's effectiveness. (redorbit.com)
  • inserts
  • Drug labels-sometimes called the package inserts-are notoriously complicated documents, printed in tiny script that can stretch on for dozens of pages. (beasleyallen.com)
  • For the more than 20 million people living with vision loss, not being able to read drug container labels and package inserts is a scary reality and a significant public health challenge. (afb.org)
  • oncology
  • On December 17, 2010, NCCN convened the NCCN Oncology Policy Summit: Off-Label Drug Use and Compendia in Washington, DC. (nccn.org)
  • FDA's
  • If approved, success of the drug-device (combination) will likely be determined not by the timing of the agency's decision, but by the wording of the FDA's drug label. (cbsnews.com)
  • agency's
  • They relied not on express language in a statute enacted by Congress, as in Riegel, but on what might be implied from federal regulatory standards and policies - in this case, from the drug agency's authority to approve drug labels. (nytimes.com)
  • regulation
  • Until a recent change in policy under the Bush administration, Justice Stevens wrote, the drug agency had welcomed state injury suits as a useful complement to federal regulation. (nytimes.com)
  • problems
  • He has filed litigation on behalf of D'Amato and others who say fluoroquinolones, a class of antibiotics, have caused severe health problems that the labeling didn't clearly describe in detail. (nbcconnecticut.com)
  • make
  • Labels are also especially useful for gauging the impact a recently approved competitor's drug might make. (foxbusiness.com)
  • The new format will "alleviate much of the clutter" on labels and make them "more concise and coherent," said Andrew von Eschenbach, acting FDA commissioner. (beasleyallen.com)
  • investigations
  • Although drug labeling for use in the pediatric population may be improving, the results from these investigations suggest a substantial use of agents "off-label" in children. (lww.com)
  • given
  • EDITOR-Turner et al highlight the fact that children admitted to hospital are often prescribed unlicensed drugs and drugs given outside the terms of their product licence (off label). (bmj.com)
  • health
  • The new CVS initiative will ensure that cvs.com customers who are blind can access the critical health and safety information provided in a standard print prescription label. (access-board.gov)
  • Eguale, a researcher at McGill's Dept. of Epidemiology, Biostatistics & Occupational Health, and his team used the Medical Office of the XXI Century (MOXXI) electronic health record network in Quebec to examine off-label use. (mcgill.ca)
  • Electronic health records can be used to document treatment indication at the time of prescribing and may pave the way for enhanced postmarketing evaluation of drugs if linked to treatment outcomes. (mcgill.ca)
  • regulators
  • it is encouraging that US regulators are willing to work with drug sponsors to overcome the challenges associated with the development, implementation, and interpretation of PROs. (ahdbonline.com)
  • News
  • A 2007 report in JAMA Medical News and Perspectives suggests that up to 75 percent of drugs used in cancer care in the United States are used off-label. (healthline.com)
  • closely
  • Can a generics provider establish non-infringement of a patented method of treating a disease when the label of the drug it is seeking to market closely tracks the steps of that method? (ipwatchdog.com)
  • side
  • Erectile dysfunction is not an unusual side effect for many commonly prescribed drugs today. (healthline.com)
  • Those uses and the drug's side effects must be listed on the side of the drug or device's packaging for doctor and patient review. (healthline.com)
  • It will summarize the major uses and side effects of the drug, as well as dosing. (beasleyallen.com)
  • petition
  • We note that sometimes determining whether or not a citizen petition submitted to FDA is really about a labeling carve-out issue can be difficult to discern. (fdalawblog.net)
  • Instead, they must ask the owner of the RLD (if they even still exist, which is not always the case) to do so on a voluntary basis, or can petition FDA to update the label. (raps.org)
  • In some cases, generic drugs can also be approved even if a drug's original application has been withdrawn, or may be declared the "same" (even if they have slight differences) by what's known as a suitability petition (see 21 CFR 314.93 ). (raps.org)
  • change
  • But in "a dramatic change in position" in 2006, Justice Stevens said, the agency reversed that longstanding policy not withstanding its "limited resources to monitor the 11,000 drugs on the market. (nytimes.com)
  • The biggest change to the labels will be a new summary at the beginning called "Highlights. (beasleyallen.com)
  • The change takes effect in 120 days for all new drugs and new approved uses, and phases in over seven years for medicines approved in the past five years. (beasleyallen.com)
  • dose range
  • Furthermore, they cite work that offers 4 different dose range recommendations of a common drug: oxycodone. (lww.com)
  • It pointed out that the proposed label recommends a usual target dose range (12 to 24 mg/day) and a maximum dose (24 mg/day). (ipwatchdog.com)