FDA approves new generic for Copaxone

October 06, 2017
The U.S. Food and Drug Administration has approved Mylan's Abbreviated New Drug Applications for glatiramer acetate as substitutable generic versions of Teva's Copaxone, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan will begin shipping imminently.
The FDA approved Mylan's glatiramer acetate injection 40 mg/mL for 3-times-a-week injection and 20 mg/mL for once-daily injection as therapeutic AP-rated equivalents to Copaxone® 40 mg/mL and Copaxone® 20 mg/mL, respectively, meaning if they are substituted for their branded counterpart they can be expected to have the same clinical effect and safety profile. As part of its application, Mylan submitted rigorous side-by-side analyses, including characterization data, which demonstrated that Mylan's glatiramer acetate injection 20 mg/mL and 40 mg/mL have the same active ingredient, dosage form, route of administration and strength as their branded counterpart. Mylan's glatiramer acetate injection 20 mg/mL and 40 mg/mL are available by prescription only.
In addition, Mylan is introducing Mylan MS Advocate, a comprehensive patient support service program to help patients get started on and stay on track with their physician's treatment plan for either dose strength of Mylan's Glatiramer Acetate Injection. All patients prescribed and taking Mylan's Glatiramer Acetate Injection 3-times-a-week 40 mg/mL or once-daily 20 mg/mL are eligible to enroll in the program which includes an interactive mobile app, in-home injection training, a 24/7 patient support center, co-pay assistance for eligible patients and ongoing support from an MS-experienced nurse.
For more information call 844-MYLAN MS (695-2667) or visit GlatiramerAcetate.com.

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