"Approvable" status for Copaxone syringes
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Application for Teva's Copaxone (glatiramer acetate) in prefilled syringes deemed "approvable" Sept. 21. Current multiple sclerosis agents require mixing and preparation prior to use. Teva plans to respond to the approvable letter by mid-October and anticipates that only minor issues will need to be addressed. The company predicts product launch by early 2002