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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: Don Miller who wrote (3810)	10/26/1999 9:35:00 AM
From: Biomaven	Respond to of 10280

SGP files for Claritin II in US and Europe. The Europe part is a pleasant surprise - these guys really have their act together. Tuesday October 26, 8:38 am Eastern Time Company Press Release SOURCE: Schering-Plough Corporation Schering-Plough Files U.S. Application for Desloratadine For Treatment of Seasonal Allergic Rhinitis MADISON, N.J., Oct. 26 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP - news) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking clearance to market desloratadine for the treatment of seasonal allergic rhinitis (SAR). The company also announced that it has submitted a centralized Marketing Authorization application for desloratadine to the European Union's (EU) European Medicines Evaluation Agency (EMEA). Approval of the centralized Marketing Authorization for desloratadine would result in unified labeling that would be valid in all 15 EU member states. Desloratadine is a nonsedating, long-acting antihistamine. Desloratadine, a new chemical entity, is a metabolite of the company's CLARITIN® (loratadine) nonsedating antihistamine. The U.S. and EU regulatory applications for desloratadine are based on four large, double-blind randomized clinical trials that investigated the product's activity and tolerability. Seasonal allergies affect an estimated 45 million Americans and an estimated 36 million people in the five major European countries of France, Germany, Italy, Spain and the United Kingdom. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. SOURCE: Schering-Plough Corporation