Posted by Michael Wonder on 21 Feb 2020
Baudax Bio announces FDA approval of Anjeso for the management of moderate to severe pain
20 February 2020 - U.S. commercial launch planned to commence in late April or early May 2020.
Baudax Bio today announced that the U.S. FDA has approved the new drug application for Anjeso (meloxicam injection), which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.
The Anjeso approval is supported by two Phase III efficacy studies and one double-blind, placebo-controlled Phase III safety study. The results from these studies, as well as results from four Phase II clinical studies and other safety studies, comprised the application package.
