SAN DIEGO Cadence Pharmaceuticals hopes to resubmit a regulatory approval application for an intravenous drug for pain and fever to the Food and Drug Administration within the next 30 days, Cadence said Monday.
The company has sought approval for Ofirmev (acetominophen), but received a complete response letter from the agency in February. The FDA issues a complete response letter when it has finished reviewing an approval application, but questions remain that preclude approval in its current form. The company said it had met with the FDA on Friday to discuss deficiencies in the application.
The drug’s active ingredient is the same as that used in the OTC drug Tylenol. Cadence hopes to win approval for the drug as a treatment for acute pain following orthopedic surgery and fever.