FDA accepts Teva's sNDA for Copaxone dose
Posted: Mon Jun 03, 2013 5:38 am
US FDA accepts Teva's sNDA for higher concentration dose for Copaxone
Teva Pharmaceutical Industries Ltd. announced that the US 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..... Read More - http://www.ms-uk.org/index.cfm/copaxone
Teva Pharmaceutical Industries Ltd. announced that the US 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..... Read More - http://www.ms-uk.org/index.cfm/copaxone