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Generic Drug Application Submission Downturn Continued In June

 
• By Derrick Gingery

Approvals also plummeted, but US FDA remains on a record-breaking pace.

FDA entrance sign 2016
The 48 ANDA submissions reported in June were the lowest monthly total seen in FY 2019. • Source: File photo

June continued a downturn in generic drug application submissions to the US Food and Drug Administration, which could be a potential concern about industry activity or simply the traditionally cyclical industry behavior.

Only 48 ANDAs were submitted to the agency in June, the third straight month the total has declined. The number also was the lowest submission total since January 2016.

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