Lupin gets tentative FDA nod for generic multiple sclerosis drug

Lupin Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Siponimod Tablets, in strengths of 0.25 mg, 1 mg, and 2 mg. This approval allows Lupin to potentially introduce a generic version of the drug, which will be manufactured at its Pithampur facility in India.

Siponimod Tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease. The approved tablets are bioequivalent to Mayzent® Tablets, a product of Novartis Pharmaceuticals Corporation.

The original branded drug, Mayzent®, recorded estimated annual sales of $195 million in the U.S. as of October 2025 (IQVIA MAT data). This tentative approval marks a key development for Lupin in expanding its presence in the U.S. market for neurological therapeutics.