Mylan N.V. (MYL) receives FDA approval for Copaxone 40 mg /ml generic

  

Mylan N.V. receives FDA approval for Copaxone 40 mg /ml generic

• Co announced the FDA has approved Mylan's Abbreviated New Drug Applications 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, 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.