Lupin receives FDA’s tentative approval for Siponimod tablets

Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis

Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Siponimod Tablets, 0.25 mg, 1 mg and 2 mg. This product would be manufactured at Lupin’s Pithampur facility in India.

Siponimod Tablets, 0.25 mg, 1 mg and 2 mg are bioequivalent to Mayzent Tablets, 0.25 mg, 1 mg and 2 mg of Novartis Pharmaceuticals Corporation, and indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.

Siponimod Tablets (RLD Mayzent) had estimated annual sales of US$ 195 million in the U.S. (IQVIA MAT October 2025).