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Emsam FDA Approval History

FDA Approved: Yes (First approved February 27, 2006)
Brand name: Emsam
Generic name: selegiline
Dosage form: Transdermal System
Company: Somerset Pharmaceuticals, Inc.
Treatment for: Depression

Emsam is a transdermal patch containing the monoamine oxidase inhibitor selegiline. Emsam is indicated for the treatment of major depressive disorder (MDD) in adults.

Development Timeline for Emsam

Feb 28, 2006Approval Emsam Approved - Bristol-Myers Squibb Company/Somerset Pharmaceuticals, Inc. - Treatment for Major Depressive Disorder
Jun 16, 2005Somerset Files Response to Emsam Action Letter
Feb  2, 2004Mylan Laboratories and Watson Pharmaceuticals Announce Receipt of "Approvable" Letter for Emsam

Further information

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