FDA ACCEPTS NDA FOR ORACEA

CollaGenex Pharmaceuticals reported that the FDA has accepted the company's new drug application for Oracea, an experimental treatment for the skin disorder rosacea. The application was based on the results of clinical trials involving 537 patients in 28 medical centers across the country.

Approximately 13.6 million adults in the U.S. suffer from rosacea. It primarily affects the face and is characterized by the appearance of inflammatory lesions (papules, pustules and nodules), erythema (skin redness) and telangiectasia (spider veins). If allowed to progress to a moderate-to-severe condition, rosacea can cause itching, pain and thickening of the skin.