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Whitehall seeking ibuprofen monograph status, citing 13 years of OTC marketing data.

This article was originally published in The Tan Sheet

Executive Summary

WHITEHALL SEEKING IBUPROFEN 200 MG MONOGRAPH STATUS in a citizen petition submitted to FDA Nov. 25. Whitehall-Robins Healthcare, a division of American Home Products, is asking FDA to include ibuprofen, which the company markets as Advil, in the internal analgesic, antipyretic and antirheumatic OTC drug products tentative final monograph as a single analgesic-antipyretic active ingredient labeled: "For the temporary relief of minor aches and pains associated with a cold, sore throat, headache, toothache, muscular aches, backache, premenstrual and menstrual cramps (dysmenorrhea) and for the minor pain from arthritis, and to reduce fever."
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