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Mylan receives US FDA approval for generic Copaxone

Mylan NV said the U.S. Food and Drug Administration approved its generic version of Teva Pharmaceutical Industries Ltd.'s Copaxone to treat relapsing forms of multiple sclerosis.

The FDA approved Mylan's abbreviated new drug applications for glatiramer acetate injection in 40 milligrams/milliliter and 20 mg/milliliter doses. Additionally, the company may be eligible for 180 days of generic drug exclusivity, though no formal decision was disclosed.

FDA Commissioner Scott Gottlieb recently said in a blog post that he wants to bring more competition to older complex medicines, such as drug-device combinations comprising a small-molecule chemical agent that requires the use of a metered-dose inhaler, like those for asthma, or certain injectable drugs, such as Copaxone.