Content about New Drug Application

June 29, 2010
Court upholds Crestor patent

The U.S. District Court for the District of Delaware has upheld the patent on a...

June 2, 2010
Perrigo receives FDA approval for generic Monistat-1 Combination Pack

Perrigo on Thursday announced that it has received final approval from the Food and Drug...

February 22, 2010
FDA declines to approve Bystolic as heart failure treatment

The Food and Drug Administration has declined to approve the use of a drug made...

January 3, 2010
FDA accepts NDA filing for retigabine

Valeant Pharmaceuticals announced that the Food and Drug Administration has accepted for review the new...

January 3, 2010
FDA issues complete response letter for J&J's ceftobiprole

The Food and Drug Administration has requested additional information and recommended additional clinical studies be...