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# FDA Approves Mylan’s Generic Copaxone Copies
- URL: https://www.fdaweb.com/fda-approves-mylans-generic-copaxone-copies/
- Published: 2017-10-04T12:00:00.000Z
- Updated: 2026-09-14T22:54:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139783

FDA has approved a Mylan ANDA for glatiramer acetate injection 40 mg/mL and 20 mg/mL, AP-rated, substitutable generic versions of Teva’s Copaxone, indicated for treating patients with relapsing forms of multiple sclerosis (MS). As part of its ANDAs, Mylan says it submitted “rigorous” side-by-side analyses, including characterization data to gain approval. According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA and may be eligible for 180 days of generic drug exclusivity but FDA has not made a formal determination at this time, the company says. Copaxone is the most prescribed MS treatment for relapsing forms of MS in the U.S. with brand sales exceeding $4 billion annually.