Lupin Wins US FDA Approval for Generic Sutab Tablets

MUMBAI, May 30, 2026 — Lupin Limited said today the U.S. Food and Drug Administration approved its abbreviated new drug application for generic Sutab tablets, a bowel preparation used before colonoscopies. The approval grants Lupin the right to market a copycat version of Braintree Laboratories' Sutab (sodium sulfate, potassium sulfate, magnesium sulfate) oral tablets. Sutab generated U.S. sales of about $112 million for the 12 months ended March 2026, according to IQVIA. Lupin did not disclose launch timing but said it would release the product shortly. The approval marks another step in the Indian drugmaker's push to expand its U.S. generics portfolio.