Mylan Receives First Approval for Buspirone 30 mg.Business Editors and Medical/Health Writers PITTSBURGH--(BUSINESS WIRE)--June 29, 2001 Mylan Laboratories Inc. (NYSE NYSE See: New York Stock Exchange :MYL MYL Mind Your Language MYL Made You Laugh MYL Miss You Lots MYL Meet You Later MYL Miss You Loads ) announced today that it has received approval from the Food and Drug Administration to manufacture and market Buspirone Hydrochloride bu·spi·rone hydrochloride n. An agent used in the management of anxiety disorders or for short-term relief of the symptoms of anxiety. buspirone hydrochloride BuSpar Pharmacologic class: Tablets 30 mg. As the first company to file a Paragraph IV certification, Mylan will be entitled to 180 days of exclusivity on this dosage form. Buspirone is the generic equivalent of Bristol-Myers Squibb's BuSpar(R) Tablets, which is indicated for the management of anxiety disorders Anxiety disorders A group of distinct psychiatric disorders characterized by marked emotional distress and social impairment, including generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and posttraumatic stress disorder. or the short-term relief of the symptoms of anxiety. Mylan will launch the Buspirone 30 mg. product in a few weeks. Mylan Laboratories Inc. is a leading pharmaceutical company that develops, manufactures and markets generic and proprietary prescription pharmaceutical products. The Company markets an extensive line of generic products through three business units, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., and UDL UDL Universal Design for Learning UDL Universitat de Lleida (Spain) UDL Universal Data Link UDL Urban Debate League UDL Uniformly Distributed Load (mechanics, building trade) UDL User Defined Logic Laboratories, Inc. and branded products through its Bertek Pharmaceuticals Inc. subsidiary. These products are manufactured and sold in a variety of dosage forms including immediate and extended-release oral tablets and capsules and transdermal patches as well as repackaging and marketing multi-source and single-source products in unit dose form. For more information, visit www.mylan.com. |
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