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FDA approves first generic Copaxone

4/16/2015

The U.S. Food and Drug Administration approved the first generic version of glatiramer acetate injection (Copaxone), used to treat patients with relapsing forms of multiple sclerosis. Sandoz, a Novartis company, has received approval to market Glatopa™ as a 20 mg/ml one-time-daily multiple sclerosis therapy.

In the clinical trials for Copaxone, the most common adverse reactions reported by those taking Copaxone were skin problems at the injection site (redness, pain, swelling and itching), flushing (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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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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