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Executive Summary

Wyeth's Orudis (ketoprofen) is both FDA's first new chemical entity approval of the new year and the first nonsteroidal anti-inflammatory agent indicated for the treatment of arthritis cleared by FDA since 1982. The Orudis approval on Jan. 9 maintained FDA's NCE approval momentum from the late December rush which saw 16 new compounds cleared by the agency. The Wyeth NSAID follows by two weeks the approval of J&J's Suprol (suprofen), which was cleared for use as an analgesic. Together, the two products represent the first NSAIDs cleared by FDA for any indication since the April, 1982 approval of Lilly's Oraflex and Pfizer's Feldene. Orudis is indicated "for the acute or long term treatment of the signs and symptoms of rheumatoid and osteoarthritis," according to the firm. Wyeth plans to launch the product in February. Wyeth said that labeling, currently in draft form, states that in double blind trials with 835 patients treated with Orudis for four to 45 weeks, the most common adverse experience was "minor gastro-intestinal" reactions. The firm noted that upper G-I reactions were more common than lower G-I reactions. Orudis is currently available in 30 countries, where, according to the firm's 1985 annual report, "it has established an excellent safety record." Wyeth has NDAs pending for the product for use as an analgesic, including a dysmenorrhea indication, and for acute gouty arthritis. The firm is also developing an ophthalmic preparation of the compound. Wyeth licenses the drug from the French pharmaceutical firm, Rhone-Poulenc. Approval of Orudis comes two weeks after approval of the firm's anti-arrhythmic Cordarone (amiodarone) ("The Pink Sheet" Jan. 6, p. 7). The two approvals come directly after the consolidation of American Home Product's Wyeth and Ives Rx drug units.

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