FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Gottlieb Predicts Another Record Year for Generic Approvals

Jan. 16, 2018

FDA Commissioner Scott Gottlieb predicted a second consecutive record year for generic drug approvals in 2018.

In a post on the agency’s Voice blog, Gottlieb cited 2017’s 1,027 generic approvals an all-time annual high for the agency. If current trends continue, the agency is on pace to break that record again in 2018, he said.

Gottlieb was also optimistic about other FDA action on generic drugs this year, such as prioritizing reviews of generic applications. He also referenced the agency’s plans to work to keep brand-name companies from gaming loopholes to delay the entry of generics into the market.

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