BRIEF—Baudax Bio announces PDUFA date for IV meloxicam

Shares of US specialty pharma company Baudax Bio were up more than 7% at $7.55 pre-market  today, after it announced that the US Food and Drug Administration has set a Prescription Drug User Fee Act (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’ latest complete response package relating to its 2019 complete response letter (CRL) 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 CRL the company had previously received (in March of 2019) relating to its IV meloxicam NDA.