Zydus secures USFDA approval for Generic Copaxone® Injection for Multiple Sclerosis

India, May 9 -- Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as "Zydus"), has received final approval from the United States Food and Drug Administration (USFDA) for its Glatiramer Acetate Injection in 20 mg/mL and 40 mg/mL strengths. The approved product is offered as a single-dose prefilled syringe and is the AP-rated, substitutable generic equivalent of Copaxone®.

This injectable therapy is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS in adults. Developed in collaboration with Chemi S.p.A., the Glatiramer Acetate Injection will be entirely manufactu...