The Mylan and Watson joint venture Somerset is discussing Phase IV and toxicology studies for its depression product Emsam (selegiline) with FDA following an "approvable" letter.

"We will work diligently with the FDA on the specific additional requirements needed to obtain approval of our Emsam product," Mylan said Feb. 2.

The "approvable" letter indicated that the drug has demonstrated efficacy in both the acute and maintenance treatment of major depressive disorder, the company stated.

Mylan said Somerset and FDA will also be discussing labeling for Emsam, specifically the agency's request that selegiline labeling include statements "addressing tyramine dietary restrictions."

The dietary issues were the subject of a "not approvable" letter for Emsam in March 2002. At that time, FDA requested three additional studies including one that was to demonstrate that the transdermal patch is not associated with the so-called "cheese effect" - hypersensitive reactions associated with the ingestion of tyramine-containing foods.

The NDA for Emsam was filed on May 25, 2001.

-John Rancourt

Mylan/Watson Emsam "Approvable"

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