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Dr. Bob is Robert Hsiung, MD,
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Posted by jrbecker on August 21, 2003, at 11:16:22
http://biz.yahoo.com/bw/030821/215136_1.html
Press Release Source: Mylan Laboratories Inc.
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.Mylan Laboratories Inc.
Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Bertek Pharmaceuticals Inc., that develop, manufacture and market an extensive line of generic and proprietary products.
For more information about Mylan, visit www.mylan.com.
Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets and distributes branded and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watsonpharm.com.
The parties caution that this press release may contain forward-looking statements, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual future results may differ materially from those expressed or implied by such forward-looking statements due to such factors including, but not limited to, changing market conditions, the availability and cost of raw materials, the impact of competitive products and pricing, the timely development, FDA approval, and market acceptance of Somerset's and its competitors' products, the outcome of litigation and other risks detailed from time-to-time in the Securities and Exchange Commission filings of Mylan Laboratories Inc. and Watson Pharmaceuticals, Inc. The parties undertake no obligation to update these statements for revisions or changes after the date of this release.
--------------------------------------------------------------------------------
Contact:
Mylan Laboratories Inc., Canonsburg, Pa.
Kris King, 724-514-1800
or
Watson Pharmaceuticals, Inc., Corona
Patty Eisenhaur or Chris Eso
909-493-5611 or 909-493-4013
Posted by blondegirl47 on August 21, 2003, at 12:19:07
In reply to Transdermal selegiline NDA resubmitted to FDA, posted by jrbecker on August 21, 2003, at 11:16:22
Great news, thanks for the update.
Blondegirl
This is the end of the thread.
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