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US Approvals Off To A Slow Start

FDA Generic Drug Approvals Are Off To Slow Start In FY 2020

Executive Summary

US FDA reports another low tally of full approvals in October, but stakeholders are not worried given the agency's history of record-breaking totals year over year.

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FDA Breaks Record On Approvals

As the FDA breaks its record for generic drug approvals in fiscal year 2019, it emphasizes the importance of consumer confidence in the safety and quality of approved generics. 

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

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.

Generic Drug Application Submission Downturn Continued In June

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

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