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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
AHMEDABAD, India, May 08, 2025--Zydus has received final approval from the USFDA for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes.
About this update from Zydus Lifesciences Limited
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":266,"url":"https://media.zenfs.com/en/business-wire.com/bc34d98f7fa92b2e9a0a0a204ae3e0af"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/JnJB2421AEzrEl.d9RNkjA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTUzMjtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/bc34d98f7fa92b2e9a0a0a204ae3e0af","width":480,"height":266}},"lazy":false},{"type":"text","content":"AHMEDABAD, India, May 08, 2025--(BUSINESS WIRE)--Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") 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.","length":337,"tagName":"p"},{"type":"text","content":"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.","length":461,"tagName":"p"},{"type":"text","content":""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."","length":413,"tagName":"p"},{"type":"text","content":"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."","length":262,"tagName":"p"},{"type":"text","content":"Punit Patel, President & CEO Zydus Pharmaceuticals USA Inc., speaking on the development, said, "The approval of Glatiramer Injection showcases our expertise ...