First Month of GDUFA II Sees Large Spike in Generic CRLs

November 16, 2017

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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