USFDA8 May 2025, 10:41 pm
Zydus receives final USFDA approval for Glatiramer Acetate Injection, the generic version of Copaxone®
AI Summary
Zydus Lifesciences Ltd. has received final approval from the USFDA for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes. The generic version of Copaxone® is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults. The approval marks Zydus' leadership in bringing complex, differentiated generics to market, and reinforces the commitment to providing a comprehensive range of therapeutic choices for patients. The development was done in collaboration with Chemi S.p.A and will be manufactured entirely in Europe. Glatiramer Acetate Injection had annual sales of US$ 719mn in the United States.
Key Highlights
- Zydus receives final approval from USFDA for Glatiramer Acetate Injection, the generic version of Copaxone® 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
- Indicated for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults
- Approval underscores Zydus' leadership in bringing complex, differentiated generics to market
- Manufactured entirely in Europe in collaboration with Chemi S.p.A
- Glatiramer Acetate Injection had annual sales of US$ 719mn in the United States