Novartis nabs FDA approval for delayed MS drug

Feb 13, 2018

Novartis's Sandoz division has received U.S. approval for a larger dosage of its multiple sclerosis drug Glatopa, which ends a delay that has seen its rival generics sneak past to market.

The U.S. Food and Drug Administration (FDA) approved a 40 milligrams per milliliter injection of the Novartis copy of Teva's blockbuster Copaxone.

In 2015, Sandoz started to sell a 20 mg/ml Glatopa dosage to patients in the United States with relapsing MS. But the company has lost out on possibly millions after the 40 mg/ml version of the treatment was pushed back after contamination issues at the Pfizer fill-and-finish plant it employed.

Read the Reuters report