Veloxis Sues FDA Over Failure To Approve Organ Rejection Drug

Veloxis Pharmaceuticals Inc. Dec. 16 sued the Food and Drug Administration seeking a court order requiring the agency to immediately approve the company’s organ rejection drug Envarsus XR (tacrolimus extended-release tablets) (Veloxis Pharmaceuticals, Inc. v. FDAfiled).

On Dec. 18, Judge Reggie B. Walton of the U.S. District Court for the District of Columbia denied without prejudice Veloxis’s motion for a preliminary injunction and granted the FDA’s motion to stay the case pending final agency action on the matter. He scheduled a status hearing in the case for Jan. 14, 2015.

The suit concerns the FDA’s determination that a ...