India, March 23 -- Sanofi (SNYNF, SNY) said that the U.S. Food and Drug Administration 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 step.
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