Motrin Suspension
This article was originally published in The Tan Sheet
Executive Summary
Waxman/Hatch marketing exclusivity reportedly extended for up to an additional 180 days under FDAMA provision that extends exclusivity for studies in pediatric populations. McNeil applied for an extension based on its earlier switch trial. Exclusivity for the product was set to expire June 16. Alpharma and Perrigo have entered into a joint licensing agreement to market, sell and distribute the OTC children's ibuprofen suspension in the U.S. The launch is expected to coincide with FDA's final approval in late 1998, Alpharma says...