Lupin receives tentative U.S. FDA approval for Siponimod Tablets
Approval covers 0.25 mg, 1 mg and 2 mg strengths for multiple sclerosis treatment
Lupin 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 in 0.25 mg, 1 mg and 2 mg strengths.
According to Lupin, the product will be manufactured at the company’s facility in Pithampur, India.
Lupin stated that Siponimod Tablets in the approved strengths are bioequivalent to Mayzent Tablets, 0.25 mg, 1 mg and 2 mg, of Novartis Pharmaceuticals Corporation. The product is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing remitting disease and active secondary progressive disease in adults.
The company cited IQVIA MAT data for October 2025 estimating annual U.S. sales for Siponimod Tablets (RLD Mayzent) at USD 195 million.