Analysis Shows FDA Approvals for Generics Rising Year-Over Year

Two months into the new federal fiscal year, generic approvals are faring considerably better compared to the same year-ago time frame, according to the FDA’s Generic Drug Program database.

A review of the agency’s statistics for October and November show that the FDA approved 112 generic drugs (51 in October and 61 in November), a significant leap from the same time frame in fiscal 2015, when the agency approved only 73 (45 in October, 28 in November).

Tentative agency approvals for generic medications also spiked in fiscal 2016, with the FDA giving provisional approval for 27 between October and November of 2015 (21 in October, 6 in November), compared to 17 for the same months in fiscal 2015 (10 in October, seven in November).

Agency statistics show that withdrawals remained flat over the time frame, with 18 in the current fiscal year (all in October) and the same number for the first two months of fiscal 2015 (six in October, 12 in November).

ANDAs Fall Sharply

However, submissions of abbreviated new drug applications for generics fell sharply, the data show. For the first two months of fiscal 2016, drugmakers submitted only 35 ANDAs, all in October. By comparison, the generics industry submitted 77 in the first two months of fiscal 2015, with 50 submitted that October and 27 submitted the next month.

The FDA has a backlog of unprocessed ANDAs that number in the thousands, although it has taken steps this year to address it (Generic Line, Oct. 28).

Similarly, submissions of changes to ANDAs (changes being effected supplemental filings) also saw a sharp decline year-over-year, with 625 submissions in fiscal 2016 (all in October), compared to 825 for the first two months of fiscal 2015 (473 in October, 385 in November).

Prior approval supplemental filings also saw a decline for that time frame, with 36 in fiscal 2016 (all in October) and 67 in the first two months of fiscal 2015 (45 in October, 22 in November). — Cameron Ayers


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