Acella Pharmaceuticals, LLC, launched Loutrex Topical Cream following a successful 510(k)notification with FDA, which determined that Acella's 510(k) submission was equivalent to another legally U.S.-marketed device and at least as safe and effective as the predicate.

Loutrex is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. The product helps relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

"I would like to thank Acella's Research and Development Team and Akesis, LLC (Lake Wylie, SC) for their work with the FDA to help get Loutrex to our customers," stated Allen Fields, Vice President, Head of Research and Development for Acella Pharmaceuticals.