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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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
