FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Reports Record Generic Approvals

Nov. 29, 2018
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In a new record month for generic drug approvals, the FDA approved 110 generics and granted tentative approvals to 18 more in October.

 Over the past two consecutive years, the agency approved record numbers of generic drugs, said Commissioner Scott Gottlieb. “Now we’re beginning the new fiscal year by breaking another record, this time with the highest number of approved or tentatively approved generics ever in a month.”

The approvals included 23 first generics for brands that previously lacked competition as well as 17 complex generics.

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