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Executive Summary

LEDERLE ORAL CEPHALOSPORIN SUPRAX (CEFIXIME) APPROVED on April 28 after a nearly three-year review at FDA. The initial NDA submission for Suprax was filed in June 1986. Lederle plans to launch the new third generation cephalosporin by the third quarter of 1989. Cefixime is licensed for marketing in the U.S. from the Japanese firm Fujisawa. Biocraft will manufacture the product for Lederle. Suprax is indicated for use in treating otitis media, acute bronchitis,acute exacerbation of chronic bronchitis, tonsilitis, urinary tract infections and pharyngitis. FDA approved the drug in 200 mg and 400 mg tablets for adults. The recommended dosage is one or two tablets a day. The recommended pediatric dose of the liquid suspension formulation is 8 mg/kg. Suprax is the second cephalosporin antibiotic approved by the FDA so far this year. Wyeth-Ayerst's cefpiramide was approved in late January; however, the company has indicated that its marketing plans for the drug are "indefinite." To date, FDA has approved three new chemical entities in 1989 -- the other approval was for Schering-Plough's Eulexin.

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