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Higher dose of MS drug Glatopa finally gets US approval

Sandoz, a Novartis division, has announced US Food and Drug Administration (FDA) approval and launched a 40 mg/ml dose of Glatopa, a glatiramer acetate injection.

Glatopa 40 mg/ml is FDA-approved as a fully-substitutable, AP-rated generic version of Copaxone. The therapy is for the treatment of relapsing forms of multiple sclerosis (MS) and is administered three times-a-week. Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals and Sandoz and is produced in the US.

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.

Sandoz GlatopaCare will offer a free co-pay support program to qualified patients. To help increase patient confidence with administering injections, patients will receive personalised injection training, 24-hour access to nurses for Glatopa-related questions and a free Starter Kit, which includes the Glatopaject injection device, designed to work with both Glatopa 20 mg/mL and 40 mg/mL prefilled syringes.

Glatopa is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. For more information visit

Source: MS-UK

Date: 14/02/18

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