FDA Approves New Dose of Existing MS Drug

The US Food and Drug Administration (FDA) has approved a thrice-weekly 40 mg/mL dose of Glatopa (glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (MS).

Glatopa, which was first launched as a 20 mg/mL dose in June 2015 by Sandoz, can be used as a fully-substitutable, AP-rated generic version of Copaxone (glatiramer acetate injection).

Contraindications for Glatopa include patients with known hypersensitivity to glatiramer acetate or mannitol.

“The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products,” said Richard Francis, CEO of Sandoz, in a press release.

—Christina Vogt

Reference:

Sandoz announces US FDA approval and launch of Glatopa 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis [press release]. Holzkirchen, Germany. Novartis. February 13, 2018. https://www.novartis.com/news/media-releases/sandoz-announces-us-fda-approval-and-launch-glatopar-40-mgml-three-times-week-generic-option-relapsing-forms-multiple-sclerosis. Accessed on February 13, 2018.