Infants' Advil
This article was originally published in The Tan Sheet
Executive Summary
Whitehall-Robins' NDA 21-812/SE5-003 for ibuprofen oral suspension concentrated drops (50 mg/1.25 mL) is approved Jan. 12. The product is indicated for use in children ages 6-23 months. Whitehall currently markets a number of Children's Advil products in drop, suspension and tablet formulations. Infants' Advil will compete with McNeil Consumer Healthcare's Infants' Tylenol pain reliever and fever reducer products