Baudax Bio Announces Feb. 20 PDUFA Date For Intravenous Meloxica

Baudax Bio, Inc. (NASDAQ:BXRX), a specialty pharmaceutical company focused on therapeutics for acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA goal date of February

Benzinga · 01/22/2020 12:05

Baudax Bio, Inc. (NASDAQ:BXRX), a specialty pharmaceutical company focused on therapeutics for acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA goal date of February 20, 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.