Mylan Announces Final FDA Approval for Its 12 mcg/hr Fentanyl Transdermal System

PITTSBURGH, Jan. 31 -- Mylan Laboratories Inc. (NYSE:MYL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for Mylan Technologies' Supplemental Abbreviated New Drug Application for its 12 mcg/hr Fentanyl Transdermal System. This product is shipping immediately.

Mylan's Fentanyl Transdermal System was the first generic class 2 narcotic transdermal product approved by the FDA, and Mylan is now the first generic company to offer all five strengths of generic transdermal fentanyl. Fentanyl is the generic version of Alza Corporation's Duragesic® product.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.

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Source: Mylan Laboratories Inc.

Patrick Fitzgerald or Kris King
Mylan Laboratories Inc.

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