Lupin has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Siponimod Tablets (0.25 mg, 1 mg, and 2 mg). These tablets, used for treating relapsing forms of multiple sclerosis, are bioequivalent to Mayzent® and will be manufactured at Lupin’s Pithampur facility in India. The estimated annual sales for Siponimod Tablets (RLD Mayzent®) reached USD 195 million in the U.S. as of October 2025.
Siponimod Tablets Approval
Lupin Limited announced it has secured tentative approval from the United States Food and Drug Administration (U.S. FDA) regarding its Abbreviated New Drug Application for Siponimod Tablets, available in dosages of 0.25 mg, 1 mg and 2 mg. Lupin plans to manufacture the approved tablets at its Pithampur facility located in India.
Tablet Details and Market Context
The approved Siponimod Tablets (0.25 mg, 1 mg and 2 mg) are bioequivalent to Mayzent® Tablets in the same strengths. They are specifically indicated for treating relapsing forms of multiple sclerosis (MS), encompassing clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease in adult patients. According to the announcement, Siponimod Tablets (RLD Mayzent®) recorded estimated annual sales of USD 195 million in the U.S. (IQVIA MAT October 2025).
Source: BSE