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Regulatory Focus™ > News Articles > FDA Rejects Highest Number of Monthly Generic Drug Applications Ever

FDA Rejects Highest Number of Monthly Generic Drug Applications Ever

Posted 08 June 2016 | By Zachary Brennan 

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 denied approval for an all-time high (dating back to FY 2013) of 190 ANDAs and approved 53 of the applications (and tentatively approved 16).

Those 190 CRLs are a nearly 30% increase over the next highest month ever, which was also the previous month ending 16 March 2016, during which FDA rejected 147 ANDAs.

To put the 190 CRL figure in perspective, the FDA in FY 2016 (five months left to report) has already rejected a total of 879 ANDAs, more than 21% of which occurred in late March and April, which compares to a total of 1180 CRLs in all of FY 2015, 1254 in all of FY 2014 and 1251 in all of FY 2013.

FDA declined to comment on the rise in CRLs, and a spokesman told Focus, “The raw numbers of Agency actions on ANDAs vary for a variety of reasons, and we would not be able to speculate on specific causes of any change over a relatively short time period.”


On the flip side, FDA has already approved 397 ANDAs in this fiscal year, meaning the agency is on pace to nearly double the total number of ANDAs approved in the previous fiscal years for which there is raw data (the highest ANDA approval number was in FY 2015, when 492 were approved).

However, FDA has fallen back in line with its approval pace in recent months after an all-time high of 79 ANDA approvals in December 2015 (43 ANDA approvals in January, 51 in February, 60 in March and 53 in the most recent month for which there's data).

That significant uptick in ANDA approvals and rejections for the latest fiscal year is thanks to almost 1,000 new employees that FDA was able to hire thanks to the Generic Drug User Fee Amendments (GDUFA), which is meant to help take a bite out of a growing ANDA backlog, FDA told us.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), told senators in January that FDA is making significant progress in reducing that backlog, and the agency expects to 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 industry funds to ensure a more consistent timeline for generic drug approvals, FDA has had to deal with a backlog of about 6,000 ANDAs.

Woodcock said that over 90% of those 6,000 applications have received some kind of review or communication from FDA officials, and despite congressional complaints about FDA’s slowness in eliminating the backlog, which some claim limits market competition, currently there are 99 generics with only one generic competitor, 66 with two competitors, and all the rest have multiple competitors.

New Report

The new statistics on approvals and CRLs for generics comes as FDA’s Office of Generic Drugs on Tuesday also released a new regulatory science research report.

The report highlights ongoing work in the Division of Therapeutic Performance (with details on nanotechnology, postmarket surveillance, local-acting and transdermal generics) and the Division of Quantitative Methods and Modeling (with details on narrow therapeutic index drugs, physiologically-based absorption and pharmacokinetic models, pharmacokinetic/pharmacodynamics models and pharmacometrics, advances in predictive dissolution and patient substitution studies).

The report follows the release of a progress report on GDUFA, released to Congress in March, and the release of two updated dashboards on generic drug approvals and workload in February and May.

Activities Report of the Generic Drug Program (FY 2016)

Office of Generic Drugs FY 2015 Regulatory Science Research Report


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