HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Tylenol First To Move On Single Dosage For Children’s Acetaminophen

This article was originally published in The Pink Sheet

Executive Summary

Johnson & Johnson narrows its pediatric Tylenol tablets a single 160 mg dose and other manufacturers are expected to follow suit, in line with a US FDA panel recommendation.

You may also be interested in...



Naloxone Still On US House Appropriators’ Radar, But OTC Access Remains Off Screen

Committee report again includes item concerning FDA’s work on expanding access to opioid antagonist naloxone. It still doesn’t acknowledge agency’s interest in making drug available OTC in a nasal inhaler, but emphasizes access for pregnant and postpartum women.

US Appropriators Question FDA’s OTC Switch Process Overhaul, Homeopathic Market Oversight

Appropriations Committee’s report with Agriculture, Rural Development, FDA and Related Agencies FY2021 budget bill also reiterated concern about adding acetaminophen dosing information for children to OTC monograph. But its mentions of FDA initiative to expand ingredients available OTC and homeopathic market oversight were firsts.

Potential Pediatric Acetaminophen Label Changes Resurface In Tylenol Class Action Settlement

Settlement could be another milestone in the contentious history of labeling for OTC acetaminophen single-ingredient products generally, and for infant’s and children’s products specifically. Plaintiffs alleged they were misled by J&J to pay more for Infant's Tylenol even though its formulation is the same as Children's Tylenol.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

RS122768

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