Generic Approvals by FDA Maintain Upward Trend in May

July 11, 2018

Generic approvals by the FDA continued to inch upward in May after the steep decline in January but they have yet to return to the levels seen at the start of fiscal 2018.

The agency’s monthly tally of generic approvals for May was 67 compared with 66 in April, 57 in March, 32 in February and 25 in January. Fiscal 2018 got underway with 87 approvals in October.

With four months to go in the current fiscal year, the total number of generics approved is 496, compared with 763 for fiscal 2017 and 651 for fiscal 2016.

Complete responses by the agency jumped to 185 in May compared with 142 in April, but nowhere near the 325 issued in October 2017.

View today's stories