• Regulatory NewsRegulatory News

    FDA Says it Discovered Problems With Generic Version of ADHD Drug Concerta

    A generic attention deficit hyperactive disorder (ADHD) drug manufactured by Mallinckrodt has been found by the US Food and Drug Administration (FDA) to not be sufficiently equivalent to its reference drug, Concerta. Background Generic drugs are approved through FDA's abbreviated new drug application (ANDA) process. During that process, FDA is primarily concerned with data showing the generic drug is bioequivalent to the reference listed drug (RLD), sometimes referred t...
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    Will Your Generic Drug Application Get Rejected by FDA? New Guidance Documents Explain

    The US Food and Drug Administration (FDA) has released two new guidance documents intended to clarify for generic drug makers the criteria by which the agency determines which applications it will "refuse to receive" due to deficiencies in an Abbreviated New Drug Application (ANDA) filing. Background The submission of an ANDA, as with most applications submitted to FDA, involves two stages: the submission of the application to FDA, and FDA agreeing to file the applicati...
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    House Republicans Increase Pressure on FDA Proposal, Citing Agency's 'Dubious' Behavior

    A new group of House legislators is calling on the US Food and Drug Administration (FDA) to answer questions about a plan to overhaul the way in which generic drug labels are updated to reflect new safety risks, saying the plan appears to have been improperly influenced by a special interest group. Background In November 2013, FDA unveiled a new proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products . The rule wou...
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    FDA Looks to Improve Generic Drug Submission Quality in New Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance document on the content and format of generic drug submissions using the common technical document (CTD). Background Generic drug applications are regulated under Section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) , and are submitted to FDA using an Abbreviated New Drug Application (ANDA). A successful application will show that a drug is the same (as defined by FDA) as ...
  • FDA Goes into Detail About Generic Drug Stability Testing

    A new guidance document released by the US Food and Drug Administration (FDA) aims to answer some common questions regarding stability testing used to support generic drug applications. Background The guidance, ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers , is a follow-up to a draft guidance released in September 2012 , and then finalized in June 2013 . The stability studies are intended to ensure that a product maintains its pot...
  • Mylan Sues FDA, Seeking Earlier Approval for Generic Celebrex

    Generic pharmaceutical manufacturer Mylan says it plans to sue the US Food and Drug Administration (FDA) after regulators declined to grant 180 days of market exclusivity for its generic version of Pfizer's Celebrex (celecoxib). Background Under the 1984 Hatch-Waxman Act , companies are allowed to file for approval for a generic version of a drug once the original product's patent and market-based exclusivity provisions end. To incentivize companies to challenge the va...
  • FDA Declares Mission (Almost) Accomplished on Removal of High-Dose Acetaminophen Products

    More than three years after initially asking all manufacturers of acetaminophen to voluntarily withdraw products containing more than 325 mg of the drug, the US Food and Drug Administration (FDA) is declaring mission (almost) accomplished. Background In January 2011, FDA requested that manufacturers discontinue marketing high-dose versions of acetaminophen-defined as doses higher than 325 mg-due the drug causing severe liver failure in some patients. "Overdose from pr...
  • FDA: More Than 3.4 Million Hours Spent Each Year Filing New and Generic Drug Applications

    It's well known that preparing a new or abbreviated new drug application (NDA/ANDA) for the US Food and Drug Administration (FDA) is a long, arduous and time-consuming affair. And according to new data just released by the agency, it would seem that popular wisdom is indeed correct. Background On 24 March 2014, FDA put out a call for public comment on its drug application processes , which are used to support the approval of all new and generic chemical drugs, as well ...
  • In Response to Legislators, FDA Defends Proposed Generic Drug Labeling Rule

    The US Food and Drug Administration (FDA) is defending itself against critics of its proposed generic drug labeling rule, which would change the way generic drug manufacturers are able to update their labels to reflect emerging or established safety risks. Background Regulatory Focus  has written extensively about the  proposed rule , including its  legal background , initial  calls by legislators for reform , FDA's  early plans for a rule chan...
  • J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk

    Drug shortages have been a recurring problem in the US thanks to a combination of market factors, regulatory decisions made by the US Food and Drug Administration (FDA) and manufacturing problems experienced by companies. So in 2012, when Johnson & Johnson's oncology drug Doxil (doxorubicin hydrochloride liposome injection, NDA # 050718 ) started experiencing shortages, FDA unveiled an unusual plan . It would allow a similar drug, Lipodox (ANDA # 203263 ), made by ...
  • Regulators Ask: Is FDA's Generic Drug Submission Process Broken?

    Can the quality of generic drug applications to the US Food and Drug Administration (FDA) be improved, and if so, what can regulators do to improve it? So asks FDA in a new Federal Register notice published on 22 January 2014, in which the agency notes that the completeness and quality of abbreviated new drug applications (ANDA)-the application used by generic drugs-has left something to be desired by regulators as of late. Common Problems "The Office of Generic Drug...
  • EU, US Regulators Team up to take on Generic Pharmaceutical Manufacturers

    The US Food and Drug Administration (FDA) has for years struggled with an influx of generic drug applications to the Center for Drug Evaluation and Research (CDER), resulting in a massive backlog that is only just starting to clear thanks to an influx in new user fee funding. But more than just the influx of abbreviated new drug applications (ANDAs), FDA's review resources have been stretched by the fact that many generic drug manufacturers are located outside the US, m...