New and Noteworthy Information—March 2018

FDA Approves Glatopa for Relapsing Forms of MS

The FDA has approved Glatopa (glatiramer acetate injection) 40 mg/mL, as a thrice-weekly generic treatment option for relapsing forms of multiple sclerosis (MS). Doses should be administered at 48-hour intervals. The treatment is intended to be fully substitutable for Copaxone. A 20-mg/mL formulation of the drug has been available since June 2015. Glatopa is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. The most common adverse reactions with glatiramer acetate injection 40 mg/mL versus placebo are injection-site reactions such as erythema (22% vs 2%). The most common side effects of glatiramer acetate injection 20 mg/mL versus placebo are erythema, vasodilatation, rash, dyspnea, and chest pain. Sandoz, which markets Glatopa, is headquartered in Holzkirchen, Germany.

—Kimberly Williams