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In First For US OTC Market, Advil Line Extension Combines Ibuprofen And Acetaminophen

 
• By Malcolm Spicer

CDER approval of Pfizer's NDA introduces a new formulation to the US OTC market. Labeling for was approved with the requirement of adding bullet points for an “Acetaminophen liver damage warning” and an “NSAID stomach bleeding warning” on all immediate containers.

GSK adn pfizer building signage

The first OTC drug containing ibuprofen and acetaminophen will be available in the US from GlaxoSmithKline PLC following regulatory approval of a formulation that will be marketed as an Advil line extension.

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