FDA Approves Generic Option for Relapsing Forms of MS

The FDA has approved Glatiramer Acetate Injection, the first generic for Copaxone, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
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The FDA approved the injection in both 40 mg/mL for 3-times-a-week injection and 20 mg/mL for once-daily injection dosages following side-by-side analyses that demonstrated that Glatiramer Acetate Injection have the same active ingredient, dosage form, route of administration, and strength as their branded counterpart.

The most common adverse effects reported with the use of Glatiramer Acetate Injection were redness, pain, swelling, itching, lump at the site of injection, flushing, rash, shortness of breath, and chest pain.

—Michael Potts

Reference:

Mylan announces US FDA approval of first generic for Copaxone® 40 mg/mL 3-times-a-week and may be eligible for 180-day exclusivity [press release]. Hertfordshire, England. October 3, 2017. http://newsroom.mylan.com/2017-10-03-Mylan-Announces-U-S-FDA-Approval-of-First-Generic-for-Copaxone-R-40-mg-mL-3-Times-a-Week-and-May-Be-Eligible-for-180-Day-Exclusivity.