The FDA committee voted against approval of tedisamil, at this time, requesting Solvay Pharmaceuticals to provide additional information to the Agency. While not binding, the Committee’s recommendations will be considered by the FDA in its review of the new drug application for tedisamil.
The new drug application for tedisamil was filed with the FDA in December 2006. Following Solvay Pharmaceuticals’s submission of additional clinical data amending the NDA for tedisamil, FDA extended the typical 10- month review period. Under this revised timeline, Solvay Pharmaceuticals anticipates action from the FDA on or before January 19, 2008.
Laurence Downey, president and CEO of Solvay Pharmaceuticals, said: “Although we are disappointed with Committee’s vote, we remain committed to working with the FDA to determine appropriate next steps in the review of this drug application.”