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


McNeil presses FDA on analgesic/sleep-aid combo

This article was originally published in The Tan Sheet

Executive Summary

The Johnson & Johnson subsidiary asks FDA to consider data supporting a Nighttime Sleep-Aid OTC monograph indication for "relief of occasional sleeplessness when associated with minor aches and pains" in a drug product containing diphenhydramine and acetaminophen - such as McNeil's Tylenol PM. The firm's March 31 1letter notes it generated data on the drug combination's effects using the same model Wyeth used to generate data in support of the new drug application for Advil PM (ibuprofen/diphenhydramine), which launched in 2006 to challenge Tylenol PM (2"The Tan Sheet" Jan. 9, 2006). McNeil's letter follows FDA's recent 3determination that data on diphenhydramine and acetaminophen the Consumer Healthcare Products Association submitted were insufficient to demonstrate "'each active ingredient makes a contribution to the claimed effect(s)' as required by the OTC combination policy.

You may also be interested in...

Wyeth’s Advil PM Approved By FDA; Sleep Aid To Challenge Tylenol PM?

Wyeth is entering the combination sleep aid/pain reliever category with its new Advil PM, recently approved by FDA for over-the-counter sale

Roche Continues To Make The Case For Gantenerumab In Alzheimer’s Disease

The amyloid-targeting drug is years behind Biogen/Eisai’s aducanumab, but its subcutaneous administration and the GRADUATE studies’ design could give Roche’s gantenerumab an advantage.

Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug

Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug;  FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.





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