Bayer S(+)ibuprofen fever study data needed; FDA committee votes against approval.
BAYER S(+)IBUPROFEN FEVER REDUCTION STUDY NEEDED, FDA's Nonprescription Drugs and Arthritis Drugs Advisory Committees concluded at an Oct. 9 joint meeting in Bethesda, Md. The committees voted 9-1 not to recommend Bayer's S(+)ibuprofen (dexibuprofen) 200 mg caplets for approval as an OTC analgesic (NDA 20-373). Bayer's proposed indications are the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscle aches, back ache, menstrual cramps, minor pain of arthritis and temporary reduction of fever ("The Tan Sheet" Sept. 9, p. 3).
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