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Pharmaceuticals / Regulatory Affairs

FDA Partially Withdraws OTC Monograph Rule for Ibuprofen

May 16, 2018

The FDA partially withdrew a 2002 proposed rule on internal analgesic, antipyretic and antirheumatic over-the-counter drugs.

Under the initial rule, the agency’s tentative final monograph for IAAA was amended to recognize ibuprofen as generally recognized as safe and effective for OTC use, but after safety issues with ibuprofen were raised in 2014 advisory committee meetings, the agency withdrew the proposed amendments.

Ibuprofen products covered under the FDA-approved NDAs and ANDAs will not be affected by the partial withdrawal.

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