SEARCH
Quotes News NAV
Corporate News  Detailed News Markets  >  Equity  >  Detailed News
Latest News about business and investments.
Your Result on : Equity   |  News | Corporate News | Detailed News
Back
Lupin receives USFDA tentative approval for Siponimod Tablets
05-Dec-25   11:15 Hrs IST

Lupin today 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, 0.25 mg, 1 mg and 2 mg. This product would be manufactured at Lupin's Pithampur facility in India.

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

Siponimod Tablets (RLD Mayzent') had estimated annual sales of USD 195 million in the U.S. (IQVIA MAT October 2025).

Powered by Capital Market - Live News