Lupin Gets USFDA Nod for Multiple Sclerosis Drug

New Delhi, Dec 5 (PTI) Drug maker Lupin on Friday said it has received approval from the US health regulator to market a generic drug for the treatment of multiple sclerosis.

The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Siponimod Tablets in strengths of 0.25 mg, 1 mg and 2 mg, the Mumbai-based drugmaker said in a statement.

The new product would be manufactured at the company's Pithampur-based manufacturing facility.

Siponimod Tablets, 0.25 mg, 1 mg and 2 mg are bioequivalent to Mayzent tablets 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.

As per the IQVIA MAT October 2025 data, Siponimod tablets had estimated annual sales of USD 195 million in the US.

Shares of Lupin were trading 0.42 per cent up at Rs 2,100.80 apiece on the BSE.