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FDA Approves Avita Gel For The Treatment Of Acne FOSTER CITY, CA -- February 3, 1998 -- The United States Food and Drug Administration has granted marketing approval to Penederm Inc.’s Avita gel, a topical form of retinoic acid, for the treatment of acne. The cream formulation of Avita, which was approved by the FDA in January of 1997, was launched commercially in August of that year and is now being promoted by Penederm to dermatologists in the U.S. The gel formulation was awaiting the expiration of a patent held by Johnson & Johnson, which did occur, clearing the way for final approval of the product by the agency. "This product will enter the fastest-growing segment of the topical retinoid market. For the year 1997, gels represent greater than 40% of topically prescribed retinoids," said Lloyd H. Malchow, President and CEO of Penederm. "Penederm is looking forward to the publication of several scientific articles related to Avita's clinical results in the April 1998 edition of the Journal of the American Academy of Dermatology." The first commercial shipment of the product will occur in March 1998. Avita is a unique formulation of retinoic acid (tretinoin) and Penederm's patented TopiCare Delivery Compounds(R). TopiCare Delivery Compounds are liquid polymers that deposit and hold drugs and other skin care agents in the upper layers of the skin. TopiCare Delivery Compounds are currently in wide use to enhance moisturisers, cosmetics and other skin care products. Avita formulations have been tested in 1,500 patients at over 24 clinical sites in North America. Penederm has also received approval for both cream and gel formulations of the product in the United Kingdom. More information on: Avita, Penederm Inc. E-mail this page to a friend or colleague! To print, use this version