Sandoz said today that the FDA has approved its Glatopa glatiramer acetate injection as a generic version of Copaxone to treat relapsing forms of multiple sclerosis.
The therapy, which is given three days per week, is administered using the Glatopaject injection device.
The 20 mg/mL version of the MS treatment has been available in the U.S. since June 2015. The latest regulatory win for the Novartis (NYSE:NVS) company involves the 40 mg/mL injectable therapy.
“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,” Sandoz’s CEO, Richard Francis, said in prepared remarks.
