JERUSALEM — Teva Pharmaceutical Industries on Tuesday announced that the Food and Drug Administration approved its supplemental new drug application for three-times-a-week Copaxone in 40mg/mL. Daily Copaxone in 20mg/mL dosage will continue to be available.
Copaxone is administered to patients with relapsing forms of multiple sclerosis. The new formulation will allow for a less frequent dosing regimen.
“The availability of three-times-a-week Copaxone 40 mg/mL is a significant advancement for patients, as they now have the option of effective and safe treatment with Copaxone, while reducing the number of injections by 60%,” Omar Khan, M.D., professor of neurology and chair of the department of neurology at Wayne State University School of Medicine, said. “Patients in the United States can now benefit from an improved dosing regimen without compromising the known benefits of Copaxone.”
Three-times-a-week Copaxone 40mg/mL is available for shipping immediately.