Emsam still in the dark
FDA has extended the user fee date for Somerset's antidepressant patch Emsam (selegiline) by three months to Feb. 26, 2006. The extension will allow FDA to review an amendment the company submitted to the NDA following the Psychopharmacologic Drugs Advisory Committee's October review of Emsam; the committee recommended approval of the monoamine oxidase inhibitor without dietary restrictions for the 20 mg low dose (1"The Pink Sheet" Oct. 31, 2005, p. 5)...
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