Glaxo Acetaminophen Efficacy Studies Fill FDA's 1,000-MG Dose Data Gaps
This article was originally published in The Tan Sheet
Executive Summary
GlaxoSmithKline generated clinical data supporting the greater pain-relief efficacy of 1,000 mg of acetaminophen over 500-mg and 650-mg doses, urging FDA to maintain OTC status for the high dose.
You may also be interested in...
McNeil Lowers Recommended Maximum Dose For Extra Strength Tylenol
McNeil Consumer Healthcare lowers the maximum daily dose indicated on labels of Extra Strength Tylenol, the first in a series of dosing changes for the firm’s acetaminophen-containing products.
McNeil Proposes Tylenol Label Change To Keep 1,000-MG Dose Available OTC
In a bid to keep 500-mg tablets and 1,000-mg doses of acetaminophen available over the counter, McNeil Consumer Healthcare argues revised dosing instructions would address the root cause of unintentional overdose without unduly restricting access to the popular painkiller
Lower Acetaminophen Doses Recommended Despite Cost Impact, Lack Of Data
A joint advisory committee recommended as a "top priority" that FDA lower the maximum single and daily dose of acetaminophen, despite inconclusive data that the current dose poses significant hepatotoxicity risks