FDA Approves First Generic Version of Copaxone to Treat Multiple Sclerosis

The US Food and Drug Administration (FDA) announced the approval of a generic version of a medication developed to treat patients with relapsing forms of multiple sclerosis.

The US Food and Drug Administration (FDA) announced the approval of a generic version of a medication developed to treat patients with relapsing forms of multiple sclerosis.

The drug, a generic form of Copaxone (glatiramer acetate injection), was approved for a once daily 20 mg/1 ml injection.

“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,” noted Janet Woodcock, MD, in a statement from the FDA. Woodcock, who serves as director of the Center for Drug Evaluation and Research, added, “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.”

The statement said that for a generic version of a drug to be approved, “the agency requires appropriate information to demonstrate sameness for complex active ingredients,” such as glatiramer acetate.

During studies of the drug the most common adverse events reported were skin problems like redness, pain, swelling, and itching at the injection site, flushing, shortness of breath and chest pain.