J&J Viadur Promotional Aid Omits Risk Information, FDA Warning Letter Says
This article was originally published in The Pink Sheet Daily
Executive Summary
A patient disc puzzle includes no risk information, FDA said. The promotion's references to Viadur's website and toll-free number do not satisfy risk disclosure requirements.
You may also be interested in...
Valera's Vantas Prostate Cancer Implant To Launch By Year-End
Valera is assembling a 50-rep urology sales force and building inventory for histrelin. Company hopes to distinguish Vantas from the other 12-month implant, Bayer/Alza's Viadur, based on the design of the delivery system.
Valera's Vantas Prostate Cancer Implant To Launch By Year-End
Valera is assembling a 50-rep urology sales force and building inventory for histrelin. Company hopes to distinguish Vantas from the other 12-month implant, Bayer/Alza's Viadur, based on the design of the delivery system.
Topamax Promotions Draw FDA Warning Letter For Omitted Safety Information
Agency cites J&J website and sales aid for making tolerability claims without including sufficient risk information.