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FDA Clears Bactroban Cream For Infected Skin Lesions PHILADELPHIA, PA -- December 17, 1997 -- The United States Food and Drug Administration (FDA) has cleared SmithKline Beecham to market Bactroban Cream (mupirocin calcium cream, 2%), a topical antibiotic for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of Staphylococcus aureus (including methicillin-resistant Staphylococcus aureus) and Streptococcus pyogenes. In two randomized, double-blind clinical trials, Bactroban Cream demonstrated equivalent efficacy to the oral cephalosporin antibiotic Keflex (cephalexin, Dista Products and Eli Lilly). Clinical efficacy rates at follow-up were 96.1 percent for Bactroban Cream and 93.1 percent for Keflex. Results from the two clinical trials in pediatric patients between the ages of three months and 16 years old also demonstrated comparable efficacy rates of 97.7 percent for Bactroban Cream and 93.9 percent for oral Keflex. There is virtually no risk of systemic side effects or drug interactions due to Bactroban Cream. The most common side effects reported include headache (1.7 percent), rash and nausea (1.1 percent each). In addition, patients surveyed in these studies preferred topical treatment over oral therapy by a margin of more than two-to-one. Bactroban Cream will be available in 15 gram and 30 gram tubes. Bactroban Cream should be applied to the affected area three times daily for 10 days. More information on: Bactroban, SmithKline Beecham E-mail this page to a friend or colleague! To print, use this version