Mylan Laboratories Inc. Reports Positive Development From FDA Advisory Committee Vote on EMSAM(R)
Posted on: Thursday, 27 October 2005, 09:00 CDT
PITTSBURGH, Oct. 27 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration's (FDA) Psychopharmacalogic Drugs Advisory Committee voted EMSAM(R) (selegiline transdermal system) could be safely administered without dietary modifications at 20 mg. EMSAM 30 and 40 mg will be administered with tyramine dietary modifications as originally proposed by Somerset Pharmaceuticals, Inc. It should be noted that the FDA is not bound by the Committee's recommendation. Mylan Laboratories subsidiary Mylan Technologies, Inc. developed EMSAM in conjunction with Somerset Pharmaceuticals, which is a joint-venture between Mylan Laboratories and Watson Pharmaceuticals, Inc. .
EMSAM is an investigational transdermal patch for the acute and maintenance treatment of major depressive disorder. EMSAM received an "approvable" letter from the FDA on January 30, 2004. Upon final approval, EMSAM would be the first transdermal patch for the treatment of major depressive disorder. EMSAM is an irreversible monoamine oxidase inhibitor that, when applied to the skin, is designed to deliver selegiline continuously over a 24-hour period. The FDA has issued a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2005 for EMSAM.
Robert J. Coury, Mylan's Vice Chairman and Chief Executive Officer commented: "We are very pleased by the FDA Advisory Committee's recommendation. If final approval is received from the FDA, EMSAM will represent yet another significant achievement by Mylan Technologies, which has clearly established itself as an industry leader in developing and manufacturing state-of-the-art transdermal pharmaceutical products."
In December 2004, Somerset and Bristol-Myers Squibb entered into an agreement for the commercialization and distribution of EMSAM in which Mylan Technologies will be responsible for manufacturing.
About Mylan Laboratories
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.
Mylan Laboratories Inc.
CONTACT: Media: Patrick Fitzgerald, +1-724-514-1800, or Investors: KrisKing, +1-724-514-1800, both of Mylan Laboratories Inc.
Web site: http://www.mylan.com/
Source: PRNewswire-FirstCall
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