Neurontin
Executive Summary
FDA ad division objects to quality of life claims in sales aid for Pfizer's anti-epileptic Neurontin (gabapentin) in June 29 letter. The sales aid cites Neurontin Evaluation of Outcomes in Neurological Practice study, which suggests "improvement in social limitations, memory difficulties, energy level, and work limitations," FDA said. The study "is not considered to be substantial evidence for claims of QoL improvements because it is not a controlled study," the letter maintains