13 February 2018 | News
Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis
Sandoz, a Novartis division, announced the US FDA approval and launch of Glatopa® (glatiramer acetate injection) 40 mg/mL.
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).
Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals, Inc. and Sandoz and is produced in the US.
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.
"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®," said Richard Francis, CEO, Sandoz.