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Dr. Bob is Robert Hsiung, MD,
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Posted by djmmm on September 3, 2003, at 17:16:50
Mylan Laboratories and Watson Pharmaceuticals Announce FDA Acceptance of Resubmission of New Drug Application for EMSAM Antidepressant Patch
Thursday August 21, 7:04 am ET
Supplemental Clinical Data Supporting Safety and Efficacy Provided to FDA
PITTSBURGH & CORONA, Calif.--(BUSINESS WIRE)--Aug. 21, 2003-- Mylan Laboratories Inc. (NYSE:MYL - News) and Watson Pharmaceuticals, Inc. (NYSE:WPI - News) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Somerset Pharmaceutical, Inc.'s EMSAM(TM) selegiline transdermal therapy for which Somerset is seeking marketing clearance for the treatment of depression. Somerset is a joint venture between Mylan and Watson.
The amendment to the New Drug Application includes additional clinical data evaluating the safety and efficacy of EMSAM(TM) at 20mg, 30mg and 40mg doses as compared to placebo. In addition, results from a 1 year relapse study and supplemental safety studies were submitted. The FDA has provided an action date of February 1, 2004.http://biz.yahoo.com/bw/030821/215136_1.html
http://www.gotoanalyst.com/cgibin/result.exe/Use=PiperPublicResearchHighlights/30807280.pdf
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