New Doses of Generic Copaxone Approved
The FDA has approved a generic version of Teva's Copaxone.
The Food and Drug Administration has approved Mylan's Glatiramer Acetate Injection (20mg/mL and 40mg/mL), a generic version of Copaxone (Teva). Glatiramer Acetate Injection is indicated for the treatment of patients with relapsing-forms of multiple sclerosis (MS).
The FDA has designated Mylan's products as AP-rated equivalents to Copaxone, indicating that they are therapeutically equivalent with regard to safety and efficacy; the active ingredient, dosage form, route of administration, and strengths are also the same as the brand counterpart.
The mechanism by which glatiramer acetate exerts its therapeutic effect in MS is unknown, however it is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS.
Glatiramer Acetate Injection will be supplied as 20mg/mL and 40mg/mL solution for SC injection in single-dose prefilled syringes. The Company plans to make the product available soon.
Mylan anounces US FDA aproval of frst gneric for Copaxone® 40 mg/mL 3-times-a-week and may be eligable for 180-day exclusivity [press release]. Hertfordshire, England: Mylan newsroom; October 3, 2017.