GlaxoSmithKline PLC not only will market the first OTC drug in the US containing ibuprofen and acetaminophen, but it also will launch the oral analgesic with a three-year market exclusivity.
Exclusivity Awaits OTC Ibuprofen-Acetaminophen Combination As Safety Concerns Trail Ingredients
GSK will market Advil Dual Action with Acetaminophen noting potential risks for both of the product’s active ingredients with labeling highlights FDA requires. It can counter labeling about risks by noting studies show the combination has better efficacy than larger doses of each drug used separately.