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Emsam Approval History

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

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 History and FDA Approval Process for Emsam

DateArticle
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

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