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FDA Approves Acne Vulgaris Drug
The FDA approved clindamycin phosphate and benzoyl peroxide gel once-daily treatment for both noninflammatory and inflammatory acne vulgaris for patients ≥12 and older.
The drug, manufactured by Valeant Pharmaceuticals, was approved based on a clinical trial with 498 patients that demonstrated the drug reduced noninflammatory lesions by 52% versus 28% in the control group and reduced inflammatory lesions by 60% versus 31%, respectively.
Fewer than 1% of patients experienced adverse events, the most common of which were burning sensation, dermatitis contact, pruritus, and rash. In addition, serious side effect, including colitis and allergic reactions, have been reported.—Kerri Fitzgerald
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