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Zydus Lifesciences bags USFDA nod for Glatiramer Acetate Injection for relapsing forms of Multiple Sclerosis

It is indicated for the treatment of relapsing forms of Multiple Sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes.
Zydus’ generic Glatiramer Acetate Injection is an FDA-approved, AP-rated substitutable generics of Copaxone 20 mg/ml, 40 mg/ml and indicated for the treatment of relapsing forms of Multiple Sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Zydus’ generic Glatiramer Acetate Injection, developed in collaboration with Chemi S.p.A., will be manufactured entirely in Europe.
"Zydus, together with Chemi, is proud to receive FDA approval for a substitutable generic version for this important therapy," said Dr Sharvil Patel, Managing Director, Zydus Lifesciences. "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.”
Read also: Zydus Medtech, Braile Biomedica of Brazil ink global licensing pact to commercialise TAVI technology
Dr. Francesco De Santis, Chairman of Italfarmaco Group, said, "Together with our partner Zydus, we are proud to expand the availability of a cost-effective, high-quality generic treatment option for patients with relapsing-forms of Multiple Sclerosis."
Punit Patel, President & CEO Zydus Pharmaceuticals USA Inc., speaking on the development, said, “The approval of Glatiramer Injection showcases our expertise in developing complex medications and reinforces our dedication to providing accessible, high-quality healthcare solutions.”
Glatiramer Acetate Injection had annual sales of US$ 719mn in the United States (IQVIA MAT Mar-2025). The group now has 426 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
Read also: Zydus Lifesciences wins USFDA okay for cholesterol-lowering drug Niacin Extended Release
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751