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FDA Smashes Record for Most ANDA Complete Responses in one Year

Posted 19 September 2018 | By Zachary Brennan 

FDA Smashes Record for Most ANDA Complete Responses in one Year

The US Food and Drug Administration (FDA) has issued more complete responses for abbreviated new drug applications (ANDAs) in 2018 than any other year, and the numbers are not even close.

But the gap between this year and years past – 2,515 complete responses have been issued so far in 2018 vs. 1,603 in FY 2017 and 1,725 in FY 2016 – may be attributed to a spike in applications or other reasons.

David Gaugh, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines, told Focus: “Year one of GDUFA II, and the volume of completed responses, are performing consistent with expectations that were set when the new goals and metrics were negotiated. It’s important to note that as part of the migration to GDUFA II, there was a bridging process that established a goal date of July 31, 2018 for the approximately 800 applications that did not have an official goal date in GDUFA I, which very likely accounts for the perceived surge in overall applications over this time period.”

Back in January, generic drugmakers also saw a spike in complete responses that was due, at least in part, to new elemental impurity requirements.

But the rise in complete responses also has come with a steady rate of ANDA approvals. 2018 is shaping up to at least match the number of approvals in 2017, which was also an all-time high.

In terms of first generics (meaning the first competitors for their reference products), FDA has tallied a total of 57 approvals in 2018 (with three months to go), which compares with 80 approvals in 2017 and 73 approvals in 2016 (FDA counts first generic approvals on the calendar year, not the fiscal year).

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 first GDUFA. The second iteration of GDUFA, which in August 2017 was renewed, took effect 1 October 2017.

The reauthorization creates a new user fee structure, aims to help small businesses and speeds the review of generic drugs even further with 8-month priority reviews, in addition to increasing interactions between the agency and companies working on complex generics, like the EpiPen.

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Categories: Regulatory News

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