Lupin Secures Tentative FDA Approval for Siponimod Tablets
Filing Summary
Lupin Limited has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Siponimod Tablets in 0.25 mg, 1 mg, and 2 mg dosages. These tablets are bioequivalent to Mayzent® Tablets by Novartis Pharmaceuticals and are indicated for treating relapsing forms of multiple sclerosis in adults. The product will be manufactured at Lupin’s Pithampur facility in India. Siponimod Tablets had estimated annual sales of USD 195 million in the U.S. as of October 2025, according to IQVIA data.
Lupin Limited 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. The approval covers dosages of 0.25 mg, 1 mg, and 2 mg. These tablets are bioequivalent to Mayzent® Tablets of the same dosages, which are produced by Novartis Pharmaceuticals Corporation.
The Siponimod Tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The tablets will be manufactured at Lupin’s facility located in Pithampur, India.
According to IQVIA data as of October 2025, Siponimod Tablets had estimated annual sales of USD 195 million in the United States. This tentative approval allows Lupin to prepare for potential market entry upon receiving final approval.
Lupin Limited is a global pharmaceutical leader with a focus on branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company operates in over 100 markets and maintains a strong presence in India and the U.S. across various therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin is committed to enhancing patient health outcomes through its subsidiaries, which include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.