US approve launch of Sandoz’ generic MS therapy, Glatopa

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Novartis division, Sandoz, has secured the approval of US regulators for the launch of Glatopa, an AP-rated generic version of Copaxone for relapsing forms of multiple sclerosis.

Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals and Sandoz and is produced in the US.

“The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products,” said Sandoz CEO Richard Francis.

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.

It was made available in the US in June 2015.