November 30, 2005

The FDA has extended the review period for Somerset Pharmaceuticals' Emsam, an investigational transdermal patch for the acute and maintenance treatment of major depressive disorder.

The FDA was slated to issue a decision on Somerset's new drug application (NDA) for Emsam (selegiline) by the end of the month, but the agency recently informed the firm that it was delaying the Prescription Drug User Fee Act goal date by three months. The delay will give FDA reviewers additional time to analyze an amendment to Somerset's NDA submitted following the recommendations of the agency's Psychopharmacologic Drug Advisory Committee.

The FDA advisory panel met last month to discuss whether Emsam can be safely administered without dietary restrictions. The committee concluded that the 20-mg version of Emsam does not need a warning label indicating the drug can cause cardiovascular risks when consumed with certain foods, but it recommended such a warning for the 30- and 40-mg dosage strengths.

Selegiline products have been linked to hypertensive reactions associated with tyramine, an ingredient contained in several foods, including smoked meats, cheese and red wine. Somerset is a joint venture between Mylan Laboratories and Watson Pharmaceuticals.