FDA May Hit Record for Generic Approvals

The FDA is on track to top its fiscal year 2017 record for generic approvals despite receiving fewer ANDA submissions, according to the agency’s latest generic drug activities report.

The agency already hit a new record of 96 approvals for the period between June 18 and July 18, giving the go-ahead to 666 generic drugs so far in the fiscal year and granting tentative approval for 162 generics.

With just two months left in the fiscal year and an average of 67 approvals a month, the agency is poised to break the previous year’s record of 763 approvals.

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