Paxil CR Vs. IR: GI Tolerability Claim Would Require Comparative Trials - FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A claim of superior GI tolerability for GlaxoSmithKline’s Paxil CR over immediate release Paxil would need to be supported by "carefully conducted studies that would compare the CR and IR forms at equieffective points on the dose response curves," FDA Psychiatric Drug Products Team Leader Thomas Laughren, MD, said in review documents for Paxil CR’s panic disorder indication.
You may also be interested in...
Paxil CR For PMDD: FDA Decision Expected In “Coming Months,” GSK Says
GlaxoSmithKline expects to hear from FDA “in the coming months” on a pending premenstrual dysphoric disorder indication for its antidepressant Paxil CR.
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011