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"No warning label" for Emsam® (selegiline) antidepressant patch

« H E » email
posted Saturday, 29 October 2005

Mylan Laboratories Inc. Reports Positive Development From FDA Advisory Committee Vote on EMSAM®

transdermal patchPITTSBURGH, Oct. 27 /PRNewswire-FirstCall/ - Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration's (FDA) Psychopharmacalogic Drugs Advisory Committee voted EMSAM(R) (selegiline transdermal system) could be safely administered without dietary modifications at 20 mg. EMSAM 30 and 40 mg will be administered with tyramine dietary modifications as originally proposed by Somerset Pharmaceuticals, Inc. It should be noted that the FDA is not bound by the Committee's recommendation.

EMSAM is an investigational transdermal patch for the acute and maintenance treatment of major depressive disorder. EMSAM received an "approvable" letter from the FDA on January 30, 2004. Upon final approval, EMSAM would be the first transdermal patch for the treatment of major depressive disorder.

The FDA said in documents released ahead of the advisory committee meeting that all versions of the patch - 20mg, 30mg and 40mg - should carry a warning about consumption of foods rich in tyramine, an amino acid found in dairy and meat products. All drugs products based on selegiline, a monoamine oxidase inhibitor, carry dietary warnings because if patients ingest too much tyramine while taking them they can suffer dramatic elevations in blood pressure.

But the panel voted by seven to four that Somerset's clinical data on the 20mg dose of Emsam was robust enough to make the warning unnecessary.


Sources: Mylan Laboratories Inc. & PharmaTimes  (Free registration required)

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