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FDA Approves Sarecycline for Moderate to Severe Acne

Medscape Derm

Sarecycline (Seysara, Almirall), a new tetracycline-derived oral antibiotic and the first such drug in 40 years designed for dermatologic use, received FDA approval. It’s recommended for patients above nine years with inflammatory lesions associated with non-nodular moderate to severe acne vulgaris.

The tablet should be taken once a day with or without food, but with fluid to reduce esophageal irritation and ulceration.

Sarecycline’s efficacy was assessed in 12-week, placebo-controlled studies with 2,002 participants aged above nine. The results were encouraging and were apparent from about three weeks. Seysara is generally safe and well-tolerated; the most common adverse reaction being nausea.

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