Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Cites ZLB's Rhophylac Promotions For Risk Info Omissions

This article was originally published in The Pink Sheet Daily

Executive Summary

ZLB is revising a Rhophylac website and has discontinued a sales brochure and patient Q&A cited in the warning letter issued by the Center for Biologics Evaluation & Research. The "main parts" of the promotions did not include sufficient risk information, FDA says.

You may also be interested in...



Rhophylac Unapproved Use Claims Targeted In CBER Untitled Letter

ZLB Behring is falsely promoting an unapproved indication for the immune globulin product in an American Hospital Formulary Service fact sheet, FDA says.

Rhophylac Unapproved Use Claims Targeted In CBER Untitled Letter

ZLB Behring is falsely promoting an unapproved indication for the immune globulin product in an American Hospital Formulary Service fact sheet, FDA says.

ZLB Rhophylac Clears FDA

ZLB Bioplasma will make its IGIV product Rhophylac available in the U.S. in March, the company said

Topics

UsernamePublicRestriction

Register

PS060626

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel