Business EconomyPosted at: Dec 5 2025 8:43PM


Lupin gets US FDA approval for multiple sclerosis tablet

Chennai, Dec 5 (UNI) Pharmaceutical major Lupin Ltd on Friday announced that it has received tentative approval from the United States Food and Drug Administration (US 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 US, the company said.
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