US Food and Drug Administration grants Sandoz approval for larger dosage of Glatopa
15 February 2018 -

The US Food and Drug Administration (FDA) has granted approval to Sandoz, a subsidiary of Novartis, for a larger dosage of its Glatopa drug intended to treat relapsing forms of multiple sclerosis, it was reported yesterday.

The company has received approval for Glatopa 40mg/mL as a fully-substitutable, AP-rated generic version of Teva Pharmaceutical Industries' three times-a-week Copaxone 40mg/mL therapy (glatiramer acetate injection). Sandoz has developed the product under a collaboration agreement with Momenta Pharmaceuticals and it is manufactured in the US.

Momenta Pharmaceuticals stated that the product includes the same active ingredients, route of administration, strength, and dosage form as the referenced product.