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Another US FDA Approval Record: ANDAs Set A New Annual High Mark In Only 10 Months

 
• By Derrick Gingery

Office of Generic Drugs has granted full approvals to more than 800 ANDAs in fiscal year 2019, exceeding the previous mark reached in FY 2018.

Generics
The US FDA is proud of the new records, but industry says product launches are not keeping up. • Source: Shutterstock

The US Food and Drug Administration continued its break-neck generic drug approval pace, posting enough full clearances in July to once again set a new record high.

Sixty-one approvals during the month pushed the total to 814 with two months still to come in fiscal year 2019....

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