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Teva Pharmaceutical Industries Ltd Announces FDA Acceptance Of sNDA For Higher Concentration Dose Of COPAXONE


Thursday, 30 May 2013 08:02am EDT 

Teva Pharmaceutical Industries Ltd announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's supplemental new drug application (sNDA) for COPAXONE (glatiramer acetate injection) 40mg/ 1mL, a higher concentration dose of COPAXONE that offers a less frequent three times a week dosing regimen administered subcutaneously for patients with relapsing-remitting multiple sclerosis (RRMS). Currently, the approved dose for COPAXONE is 20 mg/ 1mL, which is a once a day subcutaneous injection. 

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