EmsamTreatment for Depression
Somerset Files Response to Emsam Action Letter
FDA Considers Response Complete - Issues PDUFA Review Date
PITTSBURGH and CORONA, Calif., June 16, 2005 -- Mylan Laboratories Inc. and Watson Pharmaceuticals, Inc. , today announced that Somerset Pharmaceuticals, Inc. has submitted a response to the United States Food and Drug Administration's Action letter, dated January 30, 2004, related to Emsam (selegiline transdermal system). The FDA has accepted Somerset's May 26, 2005 response as complete and has issued a Prescription Drug User Fee Act (PDUFA) goal date for these submissions of November 27, 2005.
Somerset Pharmaceuticals, Inc. is a joint venture between Mylan and Watson. Emsam is an investigational monoamine oxidase inhibitor administered transdermally for acute and maintenance treatment of patients with major depressive disorder.
About Mylan Laboratories Inc.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
Posted: June 2005
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- Mylan Laboratories and Watson Pharmaceuticals Announce Receipt of "Approvable" Letter for Emsam - February 2, 2004