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Biotech / Medical : VD's Model Portfolio & Discussion Thread

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To: Cytokine1 who wrote (6566)	3/26/1999 10:46:00 AM
From: Rocketman	Read Replies (2) of 9719

FDA Approves Sepracor's Xopenex(TM) Worlds' First Single-Isomer Bronchodilator Friday March 26, 6:01 am Eastern Time Company Press Release SOURCE: Sepracor Inc. MARLBOROUGH, Mass., March 26 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR - news) today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) to market Xopenex(TM) (levalbuterol HCl) inhalation solution in two dosage strengths for use with a nebulizer for the treatment and prevention of bronchospasm. Xopenex is the therapeutically active (R)-isomer of racemic albuterol. Racemic albuterol, an equal mixture of (R) and (S) isomers, is the world's leading bronchodilator for asthma, with estimated worldwide sales of $1.2 billion in 1998. In Sepracor's clinical trials, Xopenex demonstrated excellent safety and efficacy, and a duration of action that lasted up to 8 hours. ''It appears the removal of the unnecessary (S)-isomer results in a purer and more potent drug,'' said Harold S. Nelson, M.D., Senior Staff Physician in the Department of Medicine at National Jewish Medical and Research Center and lead investigator in Xopenex Phase III clinical trials. ''For reasons that have not yet been clarified, the (S)-isomer when exposed to the patient in racemic form has been shown to interfere with the overall efficacy of the (R)-isomer.'' MORE AT: biz.yahoo.com

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