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ANDA Approval Decline Continues, But Why?

 
• By Derrick Gingery

US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.

Down arrow with people watching
What does the decline in ANDA approvals and complete response letters issued say about the FDA generics program? • Source: Alamy

Full abbreviated new drug application approvals by the US Food and Drug Administration reached a new trough for fiscal year 2021 in June and now are on pace for the lowest annual total in four years.

The FDA reported 23 July that it granted 45 full ANDA approvals in June, which was one fewer than the...

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