Teva Pharmaceutical Industries Ltd. (TEVA) Tuesday said the U.S. Food and Drug Administration has approved its supplemental new drug application for three-times-a-week Copaxone 40mg/mL.
This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis. In addition to the newly approved dose, daily Copaxone 20 mg/mL will continue to be available.
"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 percent," said Omar Khan, M.D., Professor of Neurology and Chair of the Department of Neurology, Wayne State University School of Medicine, Detroit, MI.
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