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 approves Advil Congestion Relief

This article was originally published in The Tan Sheet

Executive Summary

FDA approves Pfizer's Wyeth Consumer Healthcare's Advil line extension for relief of cold and flu symptoms including headache, fever and sinus pressure. Advil Congestion Relief tablets (ibuprofen 200 mg/phenylephrine 10 mg) also claims to reduce swelling of nasal passages and temporarily restore freer breathing through the nose, according to FDA's May 27 1approval of Wyeth's new drug application. The firm must conduct a battery of post-marketing studies on Advil Congestion Relief's pharmacokinetic and pharmacodynamic effects on pediatric populations, FDA says. Wyeth originally was interested in launching an ipuprofen/phenylephrine combination in 2006 when sales restrictions on pseudoephedrine products, such as Advil Cold & Sinus, went into effect (2"The Tan Sheet" April 24, 2006). The Advil Congestion Relief NDA was filed in July 2009
Advertisement
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS104176

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