FDA issues non-appro letter for IMPAX' Vadova

US drugmaker IMPAX Laboratories has received a non-approvable letter from the Food and Drug Administration concerning its New Drug Application for its oral Parkinson's disease drug Vadova (carbidopa/levodopa). The letter cites several deficiencies in the application, including observations resulting from an FDA inspection of the contract laboratory employed to perform bioequivalence studies. IMPAX is seeking a meeting with the agency to review the comments in detail and says it is "unable to predict whether, and if so when, Vadova might be available for commercial launch."