The higher 40-mg dosage is injected three times a week instead of daily injections of the currently approved 20-mg dosage.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced that the US Food and Drug Administration (FDA) will review the company's application for higher dosage Copaxone for the treatment of multiple sclerosis. The higher 40-mg dosage is injected three times a week instead of daily injections of the currently approved 20-mg dosage.
"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 Teva Chief Scientific Officer Dr. Michael Hayden.
Published by Globes [online], Israel business news - www.globes-online.com - on May 30, 2013
© Copyright of Globes Publisher Itonut (1983) Ltd. 2013