FDA approves Advil Congestion Relief

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