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US FDA Generic Approvals Break 900 Barrier In FY 2019

 
• By Derrick Gingery

The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.

Female athletes running towards finish line on track field
In an announcement of the ANDA approval record, Acting US FDA Commissioner Norman Sharpless said the generic program "continues to impress me." • Source: Shutterstock

Despite a slower final four months, the US Food and Drug Administration pushed its record-breaking generic drug approval total above 900 and for the first time issued more full approvals than received submissions in a single year.

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