Lupin secures tentative USFDA nod for multiple sclerosis drug Siponimod

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-12-05 05:40 GMT   |   Update On 2025-12-05 05:40 GMT
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Mumbai: Global pharma major Lupin Limited has announced that the company 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, to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.
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Multiple sclerosis is a condition that happens when the immune system attacks the brain and spinal cord.
Symptoms of multiple sclerosis vary from person to person and depend on the location and severity of nerve fibre damage. These often include vision problems, tiredness, trouble walking and keeping balance, and numbness or weakness in the arms and legs. Symptoms can come and go or last for a long time.
The causes of multiple sclerosis are not known but a family history of the disease may increase the risk.
Siponimod Tablets (RLD Mayzent) had estimated annual sales of USD 195 million in the U.S. (IQVIA MAT October 2025).

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.

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