Kamis, 15 Februari 2018

FDA Clears Higher-Dose Glatopa Generic for MS

FDA Clears Higher-Dose Glatopa Generic for MS


The US Food and Drug Administration (FDA) has approved Glatopa (Sandoz), 40 mg/mL injection, a generic version of the multiple sclerosis (MS) drug glatiramer acetate (Copaxone, Teva Pharmaceuticals).

The product is a fully substitutable, AP-rated generic version of Copaxone 40 mg/mL, three times weekly for relapsing forms of MS, Sandoz said in a news release.  

Glatopa 40 mg/mL joins Glatopa 20 mg/mL, which was approved in the United States in 2015.

Sandoz GlatopaCare offers a $0 copay support program to qualified patients. The company also offers patients personalized injection training, 24-hour access to nurses for product-related questions, and a free starter kit, which includes the Glatopaject injection device, designed to work with both the 20-mg/mL and 40-mg/mL prefilled syringes.

Full prescribing information for the product is available online. 

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