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Approvable Letter Issued for Selegiline Transdermal System
The FDA's letter indicates that Somerset has submitted sufficient data to support the efficacy of EMSAM (20mg, 30 mg & 40mg) 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. In addition, Somerset will initiate discussions with the FDA regarding proposed labeling, including FDA's request to include labeling addressing tyramine dietary restrictions while taking EMSAM.
"We will work diligently with the FDA on the specific additional requirements needed to obtain approval of our EMSAM(TM) product," said Mel Sharoky, M.D., Somerset's president and chief executive officer. "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."
Source: Mylan Laboratories Inc. and Watson Pharmaceuticals, Inc.