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.
You may also be interested in...
Wyeth’s Advil PM Approved By FDA; Sleep Aid To Challenge Tylenol PM?
Wyeth is entering the combination sleep aid/pain reliever category with its new Advil PM, recently approved by FDA for over-the-counter sale
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.