News
FDA accepts refiling of intravenous (IV) meloxicam for the management of moderate to severe pain.- Baudax Bio
Baudax Bio, Inc. a specialty pharmaceutical company focused on therapeutics for acute care settings, announced that the FDA has set a PDUFA goal date of 2 February 2020 for its decision on the New Drug Application (NDA) for intravenous (IV) 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 (CRL) and appeal filing, seeking approval for IV meloxicam..
Condition: Pain:Post Surgical
Type: drug