FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

First Month of GDUFA II Sees Large Spike in Generic CRLs

Nov. 17, 2017
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In the first month of the GDUFA II program, the FDA sent 325 complete response letters to generics manufacturers — far more than the high of 190 seen in August of the fiscal year before.

October also saw 87 generics approved, plus 14 tentatively — slightly higher than the fiscal 2017 average of 63 applications approved per month. The FDA also received 65 new ANDA submissions.

In addition, the agency has begun delineating first-cycle generic approvals, withdrawals, ANDA amendments, discipline review letters, pre-submission facility correspondence and information requests —  although no data in those categories has been posted yet for last month.

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