Par Megace ES approved
Executive Summary
FDA clears Par's appetite stimulant Megace ES July 5 for the treatment of anorexia, cachexia or an unexplained significant weight loss in AIDS patients. The company filed an NDA for the concentrated form of megestrol acetate oral suspension under the 505(b)(2) pathway in June 2004. The product will be launched the week of July 11 through a 59-member sales force. Megace ES is Par's first branded product approval. Megace ES will carry a wholesale acquisition cost of $390 and an average wholesale price of $487 for a one-month supply, Par said...