FDA Expands October ANDA Numbers with First-Cycle Approval Totals

December 8, 2017

The FDA fleshed out its public numbers on ANDA approvals for the first month of GDUFA II, notably underscoring 26 first-cycle approvals, plus two tentative.

Last month, the FDA published top-line numbers for October — including tentative and full approvals, complete response letters issued and ANDAs received. That month saw 87 generics approved, including the first-cycle OKs; a total slightly higher than the fiscal 2017 average.

For the first month of fiscal 2018, and new for GDUFA II, the agency began arranging approval data into additional categories, such as: first-cycle approvals, withdrawals of approved and unapproved ANDAs, refusals to receive a prior approved supplement, information requests, and discipline review letters.

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