Teva announces FDA acceptance of sNDA for a higher concentration dose of COPAXONE® given three times a week
Posted: 30 May 2013 | | No comments yet
“We are pleased that the FDA has accepted for review our sNDA…”
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.
“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.”
About COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. See additional important information at: http://www.sharedsolutions.com/redirect/PrescribingInformation.pdf. For hardcopy releases, please see enclosed full prescribing information. COPAXONE® is now approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.
