During a conference call with investors, Baudax Bio Inc. CEO Gerri Henwood let out an exuberant “woohoo!” to celebrate the FDA’s approval – after two turndowns and much haggling over data – of Anjeso (meloxicam) for moderate to severe pain. Echoing her sentiment was Piper Sandler analyst David Amsellem. “It’s nice to see the pain division finally get this one right,” he said.
Recro Pharma Inc. CEO Geraldine Henwood said the firm, in response to its appeal to the FDA on behalf of I.V. meloxicam for moderate to severe postoperative pain, got a “very lengthy letter” agreeing that safety and efficacy were sufficient for approval but “there was a need to negotiate labeling.”