FDA Approves Generic Drug for Relapsing Multiple Sclerosis

Officials with the FDA have approved Novartis' glatiramer acetate injection (Glatopa) 40-mg/mL for the treatment of multiple sclerosis (MS). Novartis also announced the launch of the generic drug, according to a company press release.

Glatiramer acetate injection received approval as a fully-substitutable, AP-rated generic of Copaxone 40-mg/mL, indicated as a 3-times per week treatment for relapsing forms of MS, according to the release.

The 40-mg/mL and 20-mg/mL formulations of glatiramer acetate will offer patients multiple dosing options to best meet their needs, according to the release.

Glatiramer acetate 20-mg/mL was previously launched in June 2015 and Novartis said that patients can expect the same services for the 40-mg/mL formulation.

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