Somerset Emsam Safety Data Should Be Collected To Remove Restrictions
Executive Summary
Somerset should amass safety data on its Emsam (selegiline) patches that would allow FDA to remove dietary restrictions on all strengths of the major depression therapy, the Psychopharmacologic Drugs Advisory Committee said Oct. 26
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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)...