Mylan reports positive FDA committee development on Emsam

By Jennifer Chiou

New York, Oct. 27 - Mylan Laboratories Inc. said the U.S. Food and Drug Administration's Psychopharmacalogic Drugs Advisory Committee voted that Emsam selegiline transdermal system could be safely administered without dietary modifications at 20 mg.

The FDA, though, is not bound by the committee's recommendation.

As originally proposed by Somerset Pharmaceuticals, Inc., Emsam at 30 and 40 mg will be administered with tyramine dietary modifications.

Mylan Laboratories' subsidiary Mylan Technologies, Inc. developed Emsam with Somerset Pharmaceuticals, a joint venture between Mylan Laboratories and Watson Pharmaceuticals, Inc.

Emsam is an investigational transdermal patch for the acute and maintenance treatment of major depressive disorder.

In December 2004, Somerset and Bristol-Myers Squibb entered into an agreement for the commercialization and distribution of Emsam, under which Mylan Technologies is responsible for manufacturing.

Mylan is a Pittsburgh-based pharmaceutical company.

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