Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for its generic version of Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, in single-dose prefilled syringes. This product is a generic alternative to Copaxone®, which is used in the treatment of relapsing forms of Multiple Sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. The approval underscores Zydus’ commitment to expanding access to affordable medications and aligns with their ongoing efforts to provide a comprehensive range of therapeutic choices for patients.

Developed in collaboration with Chemi S.p.A. and manufactured in Europe, Zydus’ Glatiramer Acetate Injection will be available as an FDA-approved, AP-rated substitutable generic of Copaxone®. The approval marks a significant milestone in the company’s ability to offer cost-effective treatment alternatives while maintaining high-quality standards. Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, highlighted that the approval demonstrates Zydus’ leadership in launching complex generics to meet patient needs across a wide range of therapeutic areas.