FDA accepts Teva Pharmaceutical's sNDA for COPAXONE

May 31 2013

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today 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.

“With a strong heritage in MS research innovation, Teva continues to demonstrate its commitment to patients by developing new treatment options to benefit the RRMS community.”

"We are pleased that the FDA has accepted for review our sNDA. If approved, COPAXONE^® 40mg/ 1mL given three times weekly will offer patients and their physicians flexibility in choosing a dosing regimen that works best for them, built upon the proven efficacy and established safety track record that COPAXONE^® offers," said Michael Hayden, M.D., President of Global R&D and Chief Scientific Officer, Teva Pharmaceuticals Industries Ltd. "With a strong heritage in MS research innovation, Teva continues to demonstrate its commitment to patients by developing new treatment options to benefit the RRMS community."