• Regulatory NewsRegulatory News

    Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market?

    It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare. But what most people, particularly those outside the pharmaceutical industry, don’t realize is that what’s constraining the dissemination...
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    FDA Approves First Generic Version of Roche’s Blockbuster Flu Treatment

    The US Food and Drug Administration (FDA) on Thursday announced that it has approved the first generic version of Roche’s Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older. Tamiflu, first approved in 1999, earned Roche more than $3 billion back in 2009 and more than $400 million in 2015, though its effectiveness was questioned back in 2014. Now, India-based Natco and ...
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    FDA Continues Steady Reduction of Generic Drug Application Backlog

    As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US Food and Drug Administration (FDA) is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications (ANDAs). The new data (up to 1 July 2016) reveals that FDA has reduced its ANDA workload by about 500 applications in the first six months of 2016 (the ANDA dashboard recapping 2...
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    Woodcock: FDA Hits ANDA Backlog Reduction Goal Ahead of Schedule

    Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported on Monday via email that as of 1 July 2016, CDER has acted on more than 90 percent of the Generic Drug User Fee Amendments (GDUFA) backlog, thereby accomplishing the agency’s backlog commitment more than one year ahead of schedule.  Under the $1.5 billion GDUFA, which allows generic drug companies to pay user fees to FDA for a more consis...
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    Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn

    The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which the generic is based) is withdrawn for reasons other than safety or effectiveness. The guidance focuses on a problem that has long plagued the generic industry, as generic labels are required by law to mirror their reference product counterparts at the time of approval but s...
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    FDA Rejects Highest Number of Monthly Generic Drug Applications Ever

    The common refrain that the US Food and Drug Administration (FDA) has been approving an exorbitantly high number of drug applications for generic drugs, known as abbreviated new drug applications (ANDAs), to increase market competition in recent years is slowing down in recent months. In the latest release of raw data on Tuesday of approvals and complete response letters (CRLs), also known as rejections, for ANDAs, FDA said that in the month ending 16 April 2016, it...
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    FDA Slowly Chips Away at ANDA Backlog

    Although the total workload of abbreviated new drug applications (ANDAs) continues to rise, the number of ANDAs currently with the US Food and Drug Administration (FDA) has declined by about 160 ANDAs over the past three months, according the agency’s second generic drug review dashboard released on Monday. The latest data, covering the period from January through March 2016, shows that the number of ANDAs pending filing review has declined from 211 ANDAs as of 1 Janua...
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    Grouping Supplements for CMC Changes: FDA Outlines New Policy

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Tuesday released a new document outlining how supplements can be grouped together and submitted concurrently for the same chemistry, manufacturing and controls (CMC) changes to multiple approved new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biological license applications (BLAs) submitted by the same applicant. The agency says the goal of its new policy is ...
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    Generic Drug Approvals Hit New Record in 2015, FDA Report Shows

    • 13 April 2016
    The US Food and Drug Administration (FDA) approved more generic drugs in 2015 than ever before and is on track to meet all of its goals from the Generic Drug User Fee Act of 2012 (GDUFA) by 2017, according to the first annual report from FDA’s Office of Generic Drugs (OGD). More than 700 generic drugs were approved and tentatively approved in 2015, which was the highest figure ever; and in December, FDA granted the highest number of approvals and tentative approvals in...
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    FDA to Prioritize Generic Drug Applications for ‘Sole-Source’ Products

    The US Food and Drug Administration (FDA) on Friday announced it will begin prioritizing abbreviated new drug applications (ANDAs) for generic submissions for which there is currently only one manufacturer. The change, which would effectively speed up the review of so-called "sole-source" generic drugs could increase competition, help with drug shortages and may even drive down the cost of expensive generics that have no competition. The change came in the form of an upd...
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    Generic Drug Review Dashboard: FDA Offers a First Look

    As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the first time is offering an in-depth look at where it stands with industry’s abbreviated new drug applications (ANDAs). What’s clear from the new data on 2015 is that FDA continues to seek more information or require companies to correct what’s known as an “easily correctible defic...
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    FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II

    Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017. Since 2012, when the first GDUFA was created to provide FDA with indu...