FDA Accepts for Filing Mylan's ANDA for Generic Copaxone(R)
Mon, 09/14/2009 - 4:33am
Mylan Inc. has announced that the 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(R), 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.