BMS Receives FDA Approval for Transdermal Antidepressant

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ePT--the Electronic Newsletter of Pharmaceutical Technology

BMS Receives FDA Approval for Transdermal Antidepressant

Bristol-Myers Squibb Company (Princeton, NJ, and Somerset Pharmaceuticals Inc. (Tampa, FL, have received approval from the US Food and Drug Administration (Rockville, MD, for the “Emsam” selegiline transdermal system. Somerset Pharmaceuticals is a joint venture between Mylan Laboratories Inc. (Canonsburg, PA, and Watson Pharmaceuticals Inc. (www. Corona, CA,       

The product is the first transdermal patch for the treatment of a major depressive order in adults, reported Bristol-Myers Squibb in a company release. Emsam, a transdermal delivery system manufactured by Mylan for Somerset, is a monoamine oxidase inhibitor designed to relieve depressive symptoms.

BMS receives approval for new indication for Erbitux


Bristol-Myers Squibb also has received FDA approval for Erbitux (cetuximab), an IgG1 monoclonal antibody, for use in treating squamous cell carcinoma of the head and neck. This is the second indicated tumor type for Erbitux, which was previously approved as a combination therapy with irinotecan for treating colorectal cancer.