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

Novartis' Maalox Total Relief Rebranding Reflects FDA AER Evolution

This article was originally published in The Tan Sheet

Executive Summary

FDA's request that Novartis rebrand a Maalox line extension is the latest illustration of the agency taking action based on a relatively small number of serious adverse event reports

You may also be interested in...



Draft Guidance On Developing Drug Names Calls For Simulation Studies

FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals. The draft notes that OTC “brand name extensions have posed problems when the same root proprietary name is used for multiple products.”

Draft Guidance On Developing Drug Names Calls For Simulation Studies

FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals. The draft notes that OTC “brand name extensions have posed problems when the same root proprietary name is used for multiple products.”

OTC Firms Should Improve Monograph Compliance, Registration – CDER

CDER recommends the OTC industry ensure product innovations comply with monographs or have FDA approval prior to marketing. Umbrella-branding and facility registration rank high for the drug center in 2013.

Related Content

Topics

UsernamePublicRestriction

Register

PS103822

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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