Zydus Lifesciences Gets USFDA Nod For Multiple Sclerosis Drug

Zydus Lifesciences Ltd. on Thursday said it has received final approval from the US Food and Drug Administration for its Glatiramer Acetate injection. The drug will be available in 20 mg/mL and 40 mg/mL single-dose prefilled syringes, the company said in an exchange filing.

The injection is an AP-rated, FDA-approved generic version of Copaxone and is used to treat relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

This generic has been developed in collaboration with Chemi S.p.A. and will be entirely manufactured in Europe.
According to IQVIA MAT’s March 2025 data, Glatiramer Acetate injection had annual sales of $719 million in the US.

With this approval, the group now has 426 drug approvals. As on March 31, Zydus has filed 492 abbreviated new drug applications since the process began in 2003-2004.