FY 2016 Generic Approvals by FDA: A New Record Under GDUFA

Regulatory NewsRegulatory News | 12 October 2016 |  By 

The US Food and Drug Administration (FDA) published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this month, revealing 651 approvals (though it’s 835 if tentative approvals are included), which was 159 more than the number of approvals for FY 2015 and 242 more than the agency approved in FY 2014.

But that high approval figure for last year also comes as the agency sent more complete response letters (CRLs) than any other year. The 1,725 CRLs issued in 2016 was 545 more than what FDA issued in 2015.

The 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 because of the Generic Drug User Fee Amendments (GDUFA), which is meant to help reduce the ANDA backlog.

And those reviews and approvals may pick up even more moving forward as, according to the GDUFA I performance goals (GDUFA II negotiations have recently concluded and FDA may push to eight-month and 10-month reviews of ANDAs between 2018 and 2022), FDA this fiscal year will begin to “review and act on 90 percent of complete electronic ANDAs within 10 months after the date of submission.”

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.

The 853 total ANDAs received by FDA in 2016 was also an increase of 314 applications over last year, though still significantly less than the 1,473 ANDAs received in 2014, and 115 more than FY 2013.

As far as moving forward, Bob Pollock, former acting deputy director of FDA’s Office of Generic Drugs, wrote yesterday at the Lachman Consultants blog: “So what do we think industry will look for in FY 2017?  My guess is that their expectations would be a continued increase in the number of approvals per month to approach a number that maybe closer to 75-80/month.”

Activities Report of the Generic Drug Program (FY 2016)


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