Zydus Gets USFDA Nod for Generic MS Drug

New Delhi, May 9 (PTI) Zydus Lifesciences on Friday said it has received approval from the US health regulator to market a generic medication to treat multiple sclerosis.

The company has received approval from the US Food and Drug Administration (USFDA) for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes.

The company's product is the generic version of Copaxone which is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS).


Zydus said the product, developed in collaboration with Chemi S.p.A., will be manufactured entirely in Europe.

"This approval underscores Zydus' leadership in bringing complex, differentiated generics to market, reinforcing our commitment to providing a comprehensive range of therapeutic choices for patients," Zydus Lifesciences MD Sharvil Patel said.

As per IQVIA MAT data, Glatiramer Acetate Injection had annual sales of USD 719 million in the US market.

Shares of Zydus Lifesciences were trading 0.48 per cent up at Rs 876 apiece on BSE.