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Regulatory News | 14 November 2017 | By Michael Mezher
The US Food and Drug Administration (FDA) in October issued complete responses to 325 abbreviated new drug applications (ANDAs) and approved or tentatively approved 101 ANDAs, the highest numbers in a single month since the enactment of Generic Drug User Fee Amendments (GDUFA).
FDA approved 87 ANDAs, including seven first-time generic approvals, and granted 14 more tentative ANDA approvals
The figures come from FDA's first monthly performance report for its generic drug program under GDUFA II, beating out the agency previous high of 193 complete responses in September 2016 and 100 approvals (88 approvals and 12 tentative) in June 2017.
Under GDUFA II, FDA agreed to tighter review timelines for generic drugs, committing to act on 90% of standard original ANDAs within 10 months of their submission date. The agency also has taken recent steps to expand its priority review program to a broader set of generic drugs in an effort to increase competition.
In FY2017, FDA set a record for the most ANDAs approved in a single year, with 763 approvals and 174 tentative approvals.
Most months, FDA issues between 100 and 190 complete responses to ANDAs, with the agency issuing fewer than 100 complete responses in just 19 out of 60 months under GDUFA I.
The lowest number of complete responses for ANDAs in a single month was 43 in October 2014.
Tags: ANDAs, GDUFA II, Complete Responses