Lupin Receives Tentative Approval from U.S. FDA for Siponimod Tablets

Global pharma major Lupin Limited has announced that it has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Siponimod Tablets, 0.25 mg, 1 mg and 2 mg. The product will be manufactured at Lupin’s Pithampur facility in India. Siponimod Tablets are bioequivalent to Mayzent® Tablets of Novartis Pharmaceuticals Corporation and are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Siponimod Tablets (RLD Mayzent®) had estimated annual sales of USD 195 million in the U.S. (IQVIA MAT October 2025).