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FDA Extends Review Time for Selegiline Transdermal System

TAMPA, Fla., Nov. 21 /PRNewswire/ -- Somerset Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) Division of Psychopharmacologic Drugs has issued a revised Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2006 for EMSAM(R) (selegiline transdermal system), an investigational transdermal patch for the acute and maintenance treatment of major depressive disorder. The PDUFA goal date was extended by three months in order to allow the FDA sufficient time to review an amendment to Somerset's NDA submitted following the recommendations of the U.S. Food and Drug Administration's Psychopharmacologic Drug Advisory Committee.

On October 26, 2005 the Psychopharmacologic Drug Advisory Committee voted EMSAM(R) (selegiline transdermal system) could be safely administered without tyramine dietary modifications at 20 mg. EMSAM 30 and 40 mg will be administered with tyramine dietary modifications as originally proposed by Somerset. The Committee also agreed that Somerset and Bristol-Myers Squibb could effectively communicate dietary instructions required at the higher doses, without requiring the same dietary instructions for the 20 mg dose. However, the FDA is not bound by the Committee's recommendations.

EMSAM received an "approvable" letter from the FDA on January 30, 2004 and would be the first transdermal patch for the treatment of major depressive disorder upon final approval. EMSAM is an irreversible monoamine oxidase inhibitor that, when applied to the skin, is designed to deliver selegiline continuously over a 24-hour period. In December 2004, Somerset and Bristol- Myers Squibb entered into an agreement for the commercialization and distribution of EMSAM.

Source: Somerset Pharmaceuticals, Inc.

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