Mylan Laboratories Inc. and Watson Pharmaceuticals, Inc. announced that Somerset Pharmaceuticals, Inc. has received an "Approvable" letter from the US Food and Drug Administration (FDA) for EMSAM, the company's transdermal therapy for which they are seeking an indication for the treatment of major depressive disorder. Somerset is a joint venture between Mylan and Watson.

The FDA's letter indicates that Somerset has submitted sufficient data to support the efficacy of EMSAM in the acute and maintenance treatment of major depressive disorder. Somerset has initiated discussions with the FDA to review and clarify its comments. These comments include that Somerset conduct Phase 4 post-marketing pharmacokinetic and safety studies as well as additional pharmacology/toxicology studies.

"We will work diligently with the FDA on the specific additional requirements needed to obtain approval of our EMSAM product," said Mel Sharoky, Somerset's president and CEO. "With over 2,000 depressed patients exposed to EMSAM, we are encouraged by the product's safety data and view EMSAM as an important advance in the treatment of depression. At the same time, Somerset will continue its discussions to out license EMSAM with a potential partner."