FDA approves first generic medication for treatment of MS

The FDA today granted approval for Glatopa, the first generic version of Copaxone 20 mg, according to a press release.

“Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy. The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products and further demonstrates our commitment to offer patients and payors a full range of therapeutic options,” Peter Goldschmidt, president of Sandoz US, said in a press release.

Glatopa (Sandoz), a generic glatiramer acetate 20 mg/mL daily injection, is intended for patients with relapsing forms of multiple-sclerosis.

In clinical trials, common side effects of Glatopa included injection site reactions, such as redness, pain, swelling and rash, shortness of breath and chest pain. The manufacturer noted that glatiramer acetate may interfere with immune functions.

Janet Woodcock

“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. 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,” Director of FDA’s Center for Drug Evaluation and Research, Janet Woodcock, MD, said in a press release.