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New Formulation APPROVED of COPAXONE® Offers Patients and Their Physicians Ability to Dose Less Frequently

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JERUSALEM--()--Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental new drug application (sNDA) for three-times-a-week COPAXONE® 40mg/mL, a new dose of COPAXONE®. This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis (MS). In addition to the newly approved dose, daily COPAXONE® 20 mg/mL will continue to be available. The daily subcutaneous injection was approved in 1996.

“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. “Patients in the U.S. can now benefit from an improved dosing regimen without compromising the known benefits of COPAXONE®.”

The FDA approval is based on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study of more than 1400 patients, which showed that a 40 mg/mL dose of COPAXONE® administered subcutaneously three-times-a-week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting MS

“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”

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