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

Wednesday, February 14, 2018 | FDA Approval/Clearance , Multiple Sclerosis & Immune Disorders

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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