Lupin Receives Tentative FDA Approval for Generic Siponimod Tablets

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has received tentative U.S. FDA approval for its generic Siponimod Tablets (0.25mg, 1mg, 2mg), a bioequivalent version of Novartis’ Mayzent used to treat relapsing forms of multiple sclerosis. Manufactured at the company’s Pithampur facility, the product targets a U.S. market estimated at USD 195 million in annual sales.