ATLANTA, Jan. 31, 2014 /PRNewswire/ -- Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, recently announced the approval and launch of Loutrex Topical Cream following a successful 510(k)1 notification with the Food and Drug Administration (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.
The approved 510(k) (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.
About Acella Pharmaceuticals, LLC
Acella develops markets, sells and distributes a broad portfolio of non-branded pharmaceutical and other products in the areas of Dermatology, Women's Health, Pediatrics and other applications. Acella specializes in identifying and bringing to market quality, affordable products to customers and patients. For additional information please contact Acella at 678-325-5189.
1. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. (Source: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm)
SOURCE Acella Pharmaceuticals, LLC