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McNeil presses FDA on analgesic/sleep-aid combo

This article was originally published in The Tan Sheet

Executive Summary

The Johnson & Johnson subsidiary asks FDA to consider data supporting a Nighttime Sleep-Aid OTC monograph indication for "relief of occasional sleeplessness when associated with minor aches and pains" in a drug product containing diphenhydramine and acetaminophen - such as McNeil's Tylenol PM. The firm's March 31 1letter notes it generated data on the drug combination's effects using the same model Wyeth used to generate data in support of the new drug application for Advil PM (ibuprofen/diphenhydramine), which launched in 2006 to challenge Tylenol PM (2"The Tan Sheet" Jan. 9, 2006). McNeil's letter follows FDA's recent 3determination that data on diphenhydramine and acetaminophen the Consumer Healthcare Products Association submitted were insufficient to demonstrate "'each active ingredient makes a contribution to the claimed effect(s)' as required by the OTC combination policy.
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