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Home » Lexicon, Sanofi hit with CRL on Zynquista; Recro with IV meloxicam gets one, too
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Lexicon, Sanofi hit with CRL on Zynquista; Recro with IV meloxicam gets one, too

March 25, 2019
By Randy Osborne
On the PDUFA date for Zynquista (sotagliflozin), the FDA delivered a complete response letter (CRL) to Lexicon Pharmaceuticals Inc. and partner Sanofi SA related to the NDA for the type 1 diabetes therapy, an oral dual inhibitor of sodium glucose transporter (SGLT) 1 and 2 that was previously known as LX-4211. Recro Pharma Inc. also found a CRL in its mailbox, related to the NDA for intravenous (I.V.) meloxicam for the management of moderate to severe pain.
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