FDA Issues Complete Response Letter for Zynquista™ (sotagliflozin)
Lexicon Pharmaceuticals, Inc. (LXRX)
Last lexicon pharmaceuticals, inc. earnings: 4/27 07:00 am
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Source: GlobeNewswire
PARIS and THE WOODLANDS, Texas, March 22, 2019 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista™ (sotagliflozin)*, a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin. A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form. Sanofi and Lexicon will work closely with the FDA to determine the appropriate next steps. * Sotagliflozin is an investigational drug and is under regulatory review by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). The EMA and FDA have conditionally accepted Zynquista™ as the trade name for sotagliflozin. About Lexicon Pharmaceuticals Lexicon is a fully i
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