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Mylan : FDA Approves First Generic For Copaxone 40 Mg/mL 3-Times-a-Week

Mylan N.V. (MYL) said that the U.S. Food and Drug Administration or FDA has approved Mylan's Abbreviated New Drug Applications or ANDAs for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva's Copaxone 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva's Copaxone 20 mg/mL, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis or MS, a chronic inflammatory disease of the central nervous system. 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 ANDAs, 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.

According to the FDA approval letter, Mylan was one of the first applicants to submit a substantially complete ANDA for Glatiramer Acetate Injection, 40 mg/mL, containing a Paragraph IV certification. Therefore, Mylan and other first filers may be eligible for 180 days of generic drug exclusivity but FDA has not made a formal determination on exclusivity at this time.

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.

by RTT Staff Writer

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