Baudax Bio announces PDUFA date for intravenous meloxicam

Baudax Bio

22 January 2020 - Baudax Bio today announced that the U.S. FDA has set a PDUFA goal date of 20 February 2020 for its decision on the new drug application for intravenous meloxicam for the management of moderate to severe pain. 

The assignment of this PDUFA goal date follows the FDA’s acceptance of Baudax’s latest complete response package relating to its 2019 complete response letter and appeal filing, seeking approval for IV meloxicam.

In October 2019, Baudax (through its former parent, Recro Pharma) received a written decision from the FDA granting the appeal of the complete response letter the Company had previously received (in March of 2019) relating to its IV meloxicam NDA.

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier