New Dose of Generic Glatiramer Acetate Injection for Treatment of Relapsing Multiple Sclerosis Approved by Food and Drug Administration

Wednesday, February 14, 2018


Sandoz announced that the Food and Drug Administraion (FDA) had approved a generic form of glatiramer acetate (Glatopa,Sandoz) in injectable form at a dose of 40 mg/mL 3 times per week for relapsing forms of multiple sclerosis (MS). The launch of this dose of glatiramer acetate by Sandoz provides patients a complete range of dosing options with a generic form of the drug. A 20 mg/mL dose was previously launched by Sandoz in June 2015.

Glatopa (glatiramer acetate injection) 40 mg/mL is FDA-approved as a fully-substitutable, AP-rated generic version of Copaxone (Teva) and was developed under a collaboration agreement between Momenta Pharmaceuticals, Inc. and Sandoz. Glatopa is produced in the US.

“The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products. We look forward to bringing this product to patients and healthcare professionals and providing a full range of patient support,” said Richard Francis, CEO, Sandoz.

Sandoz patient services program GlatopaCare will offer a $0 co-pay support program to qualified patients and personalized injection training, as well as 24-hour access to nurses for Glatopa-related questions. Patients in this program will also receive a free starter kit that includes an injection device designed to work with prefilled syringes.

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