WASHINGTON Solvay Pharmaceuticals said it will continue to work closely with the Food and Drug Administration to fully address the questions raised by members of the Cardio-Renal Advisory Committee about its tedisamil drug, according to published reports.
The committee held a meeting to consider the tedisamil drug as a treatment for rapid conversion of recent onset atrial fibrillation to normal sinus rhythm. The committee voted against approval of tedisamil at the time, requesting that Solvay Pharmaceuticals provide additional information.
“Although we are disappointed with today’s vote, we remain committed to working with the FDA to determine appropriate next steps in the review of this drug application,” said Laurence Downey, chief executive of Solvay Pharmaceuticals.
The company said it expects action from the FDA on or before Jan. 19.