IBUPROFEN ADVERSE EVENT REPORTING, SAFETY/EFFICACY RECOGNITION NEEDED, and therefore the drug should not be included in FDA's analgesic, antipyretic and antirheumatic drug products tentative final monograph, McKenna & Cuneo asserts in April 22 comments to the agency. The D.C. law firm opposes Whitehall-Robins Healthcare's citizen petition asking that ibuprofen (200 mg), which Whitehall sells as Advil, be added to the monograph as a single analgesic-antipyretic active ingredient. The American Home Products division filed the petition Nov. 28, citing the drug's 13-year marketing history and noting that monograph inclusion would "simplify the administrative burden" on both companies and FDA ("The Tan Sheet" Dec. 8, 1997, p. 4).
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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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