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At Least 249 ANDAs Are in Jeopardy: Are You Delinquent in Your Annual Reports?

January 9, 2020

The U.S. Food and Drug Administration (FDA) announced plans to withdraw the approval of 249 Abbreviated New Drug Applications (ANDAs) since their manufacturers have failed to submit annual reports. This should serve as a wakeup call to all delinquent ANDA holders.

Be mindful that all ANDA holders are required to submit annual reports for approved ANDAs under 21 CFR Sections 314.81 and 314.98.

If you are on this list, FDA will provide an opportunity to request a hearing to appeal the decision by filing a written request and providing the agency with a detailed, reasoned statement why the ANDA should not be withdrawn.

View the released FDA list.

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Braginsky, Philip Partner and Co-Chair of Intellectual Property Group and Pharmaceutical and Biologics Practice and China Practice Partner and Co-Chair of Intellectual Property Group and Pharmaceutical and Biologics Practice and China Practice 212.216.8065 VCard

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