FDA: generic copaxone approved for multiple sclerosis

FDA: generic copaxone approved for multiple sclerosis
The first U.S. generic version of Copaxone (glatiramer acetate injection) has been approved by the Food and Drug Administration to treat multiple sclerosis.

(HealthDay)—The first U.S. generic version of Copaxone (glatiramer acetate injection) has been approved by the Food and Drug Administration to treat multiple sclerosis.

The brand-name drug is produced by Israel-based Teva Pharmaceuticals. License to produce the of Copaxone was issued to the Swiss-based drug maker Sandoz, the FDA said Thursday in a news release.

The most common side effects of Copaxone include injection-site redness and pain, vasodilation, rash, shortness of breath, and chest pain.

"Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement. "Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand-name product."


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