FDA accepts Mylan's application for MS generic

PITTSBURGH The Food and Drug Administration has accepted a generic drug maker’s approval application for a version of a multiple sclerosis drug.

Mylan announced Monday the FDA’s acceptance of its application for glatiramer acetate injection in the 20 mg-per-milliliter strength. Mylan has an agreement with NATCO Pharma, whereby Mylan receives exclusive distribution rights for pre-filled syringes of the drug in the United States, Canada, Europe, Australia, New Zealand and Japan.

The drug is a generic version of Teva’s Copaxone, which had global sales of $2.26 billion in 2007, according to Teva financial reports. According to the FDA’s Orange Book database, Teva’s patent on Copaxone, which the company considers its leading innovative product, expires in 2014.