FDA Generic Drug Approvals Remain Low in February

The FDA’s approvals of generic drugs picked up slightly in February after January’s steep dropoff, while overall ANDA submissions dropped sharply, according to the agency’s latest monthly report.

The Office of Generic Drugs approved 32 ANDAs in February, up from 25 the previous month. Submissions declined from 91 in January to 55 in February. Overall approvals for fiscal year 2018 stand at 306, as opposed to the 539 approvals at this same stage of fiscal 2017.

Last month, Commissioner Scott Gottlieb said the decline in approvals was temporary, attributing the slowdown to drugmakers’ implementation of the agency’s new impurity guidelines.