FDA Review of Schwarz’s Neupro Shaped By Parkinson’s Pharmacovigilance
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA’s review of the Schwarz Neupro (rotigotine) NDA illustrates the important role pharmacovigilance has come to play in the agency’s consideration of new Parkinson’s disease treatments.
You may also be interested in...
Restless Leg Syndrome Market Prepares To Move As GSK, UCB Advance Drugs
UCB could bring the first competitor to GlaxoSmithKline's Requip (ropinirole) for restless leg syndrome to market later this year after submitting an sNDA for Neupro (rotigotine) for RLS
Renal Effect Seen In Neupro Lab Values, But Not Robust Enough For Label
Data supporting an FDA safety reviewer's concerns that laboratory value changes seen in Neupro studies could indicate an effect on renal function were found insufficiently robust for inclusion in labeling by supervisory reviewers, FDA documents show
Neupro Clinical Development
Neupro Clinical Development