Mylan files in FDA for generic Copaxone for Multiple Sclerosis.

Mylan Inc. announced that its abbreviated new drug application (ANDA) for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the FDA. This product is the generic version of Teva's Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of Multiple Sclerosis (MS).

Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5 million for the 12 months ending June 30, 2014.