FDA issues complete response letter for Zynquista (sotagliflozin)

Sanofi

22 March 2019 - The U.S. FDA issued a complete response letter 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 complete response letter 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.

Read Sanofi press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US