FDA accepts for filing Mylan's application for generic Copaxone

PITTSBURGH -- Mylan Inc. (NASDAQ: MYL) has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Mylan Pharmaceutical Inc.'s abbreviated new drug application (ANDA) for Glatiramer Acetate Injection (20 mg/mL), a generic version of Teva's Copaxone®, a product indicated for the treatment of multiple sclerosis.

As previously announced, Mylan entered into a license and supply agreement with NATCO Pharma Ltd. (NATCO) which granted Mylan exclusive distribution rights for Glatiramer Acetate pre-filled syringes in the U.S. and all major markets in Europe, Australia, New Zealand, Japan and Canada. The agreement also includes an option to potentially expand into additional territories.

With headquarters in Pittsburgh, Mylan maintains a large production facility in Morgantown. Mylan is the 11th largest private company in West Virginia in 2009, according to data recently released by Workforce West Virginia.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. For more information, visit www.mylan.com.