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Pharmaceuticals / Submissions and Approvals

FDA’s Generic Approvals Continue to Break Records

Aug. 14, 2019

The FDA’s generic drug approvals  have surpassed the record set in FY 2018, the agency said Friday.

According to its latest generics drug program activities report, the agency tallied up a combined 1,028 approvals for fiscal 2019 so far, with 61 approvals and 14 tentative approvals in July putting the agency over the fiscal 2018 record of 971.

Acting FDA Commissioner Norman Sharpless noted that approvals aren’t the only measure of success for the generics drug program. The agency also continues to “work with industry to improve the quality of their applications,” he said.

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