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Acella Pharmaceuticals receives FDA 510(k) approval for seborrheic dermatitis treatment

Acella Pharmaceuticals announced it has received FDA 510(k) approval for its Loutrex Topical Cream for treating seborrhea and seborrheic dermatitis.

The FDA determined that “Acella’s 510(k) submission was equivalent to another legally US-marketed device and at least as safe and effective as the predicate,” according to a press release.

Loutrex is indicated for seborrhea and seborrheic dermatitis symptoms including itching, erythema, scaling and pain by relieving dry, waxy skin and keeping the wound moist, according to the release. Acella markets, sells and distributes non-branded pharmaceutical products in dermatology, women’s health, pediatrics and other applications.