Galderma Laboratories has announced FDA approval of MetroGel (metronidazole) for the topical treatment of the inflammatory lesions of rosacea. MetroGel will be available by prescription July 29, 2005.
The FDA has accepted Santarus' new drug application for Zegerid (omeprazole) capsules 40 mg. and 20 mg. Santarus expects the FDA will complete its review or otherwise respond to the NDA by February 26, 2006. Santarus is seeking marketing approval of Zegerid Capsules for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), erosive esophagitis, duodenal ulcers and gastric ulcers.
Par Pharmaceutical announced FDA approval of Megace ES (megestrol acetate), a concentrated oral suspension for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of AIDS. Megace ES is the first branded pharmaceutical product developed by Par to be approved for marketing by the FDA.
Novartis and Procter & Gamble Pharmaceuticals have entered into an agreement for the co-promotion and further development of Enablex (darifenacin) extended release tablets for the treatment of overactive bladder in the U.S. Novartis will continue to record revenues for Enablex and will pay royalties to P&GP based on the product's performance.