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Regulatory Focus™ > News Articles > 11 > FDA Hits Monthly Generic Drug Approval Record in October

FDA Hits Monthly Generic Drug Approval Record in October

Posted 12 November 2018 | By Zachary Brennan 

FDA Hits Monthly Generic Drug Approval Record in October

With 110 approvals and 18 tentative approvals, the US Food and Drug Administration (FDA) approved more generic drugs in October than any month prior.

The 128 total approvals barely edged the 126 total approvals from July 2018. The next closest month was November 2017, with 107 total approvals. The 128 total also included 23 first generic drug approvals (i.e. for brands that lacked competition) and 17 complex generics.

The record month in October follows a record year in FY 2018, with 971 total approvals including 781 final approvals and 190 tentative approvals, which compares with 937 total in FY 2017, which was the highest number of approvals since 2016, which at the time set the previous record.

FDA Commissioner Scott Gottlieb said: “Through our efforts, generic drugs entering the market from January 2017 through July 2018 saved consumers $26 billion through the lower prices they enabled. And perhaps even more importantly, our efforts are having a real impact on reducing the number of review cycles of generic drug applications, making the process more efficient overall so that we can dedicate our resources to getting quality generic medicines to Americans sooner.”

In October, FDA also issued a series of guidance documents looking to advance the development of generic transdermal and topical delivery systems (TDS). FDA also issued 25 related product-specific guidance documents to provide recommendations for applications for such complex products. Of these, 23 were revised to update newer scientific understanding and two were new guidances. 

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