2023-15454: Bristol Myers Products Inc.; Withdrawal of Approval of a New Drug Application for BUFFERIN (Aspirin) Tablets
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The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for BUFFERIN (aspirin) tablets. The basis for the withdrawal is that the holder of the NDA has repeatedly failed to file required annual reports for this NDA.
The agency’s own summary, as published.
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