Sandoz asserts FDA’s approval for initiation of Glatopa

Novartis division, Sandoz asserted that the US FDA ha sanctioned the roll out and launch of Glatopa (glatiramer acetate injection) 40 mg/mL.

Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals and Sandoz . Glatopa (glatiramer acetate injection) 40 mg/mL is FDA-approved as a fully-substitutable, AP-rated generic version of Copaxone (glatiramer acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple sclerosis (MS).

Richard Francis, CEO, Sandoz said “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 services for Glatopa through GlatopaCare.”

Glatopa 40 mg/mL is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Glatopa 40 mg/mL, along with Glatopa 20 mg/mL, will offer patients a complete range of dosing options. Glatopa 20 mg/mL was made available in the US in June 2015. Patients can expect the same patient services for Glatopa 40 mg/mL as for Glatopa 20 mg/mL.