Office of Generic Drugs 2021 Annual Report

FDA

14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public.

This past year, the generic drug program approved hundreds of abbreviated new drug applications (ANDAs) and thousands of application supplements. The office prioritised the assessment of generic drug submissions for potential treatments and supportive therapies for patients with COVID-19, approving more than 75 original ANDAs, some in record time, and since the beginning of the pandemic, more than 1,200 supplements.

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Michael Wonder

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Michael Wonder