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Executive Summary

BEECHAM'S BACTROBAN TOPICAL ANTIBIOTIC WILL BE LAUNED IN APRILfollowing FDA approval on Dec. 3, the company said. FDA review of the Bactroban NDA took 45 months. Bactroban (mupirocin) ointment 2%, Beecham said in a Jan. 7 press release, is "the first totally new antibiotic in a topical formulation to be introduced in the United States in more than 20 years." The approved labeling for Bactroban states that mupirocin ointment "is indicated for the topical treatment of impetigo due to: Staphylococcus aureus, beta hemolytic Streptococcus, and Streptococcus pyogenes." Impetigo is a highly contagious skin disease that affects over 1.3 million Americans a year, primarily children, Beecham said. The antibiotic has been tested in over 1,300 patients in U.S. clinical trials, Beecham said. An additional 10 clinicals are currently ongoing in the U.S. with Bactroban, the company added, to evaluate its effectiveness in treating other types of infections. Labeling for the antibiotic also notes that "each gram of Bactroban ointment 2% contains 20 mg mupirocin in a bland water miscible ointment base." Beecham's price to wholesalers for Bactroban is $22.50 per carton, which contains three, 15 gm tubes of the ointment.

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