FDA Reopens Comment Period for Over-the-Counter Pain Relief Medications

Summary

The Food and Drug Administration (FDA) is extending the public comment period for a proposed rule on over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products until September 2, 2003, in response to a request for an additional 90 days to submit comments on the proposed rule, which aims to include ibuprofen as a generally recognized safe and effective analgesic/antipyretic active ingredient for OTC use and to amend regulations to include consistent allergy warnings for OTC IAAA drug products.