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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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More from Rx-to-OTC Switch

Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

Preamble ‘Poison Pill’ Could Haunt ACNU Switch Rule – House Energy And Commerce Members

 
• By Malcolm Spicer

Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.

Arkansas Law For OTC Ivermectin Sales Doesn’t Answer Dose, Format And Access Questions

 
• By Malcolm Spicer

“I’m not sure exactly if they understood how broad this actually is and what that might potentially lead to or what the follow-up would be if somebody now decides to sell a 10-milligram version of ivermectin for human use,” says food and drug regulation attorney Frederick Stearns.

More from Health

Euro Q1 Consumer Health Earnings Preview: Haleon, Reckitt, Bayer

 
• By Tom Gallen

Major Europe-based consumer health players Haleon, Reckitt and Bayer feature in this sales and earnings preview, which highlights what to look out for as these three firms report their Q1 2025 results over the coming weeks.

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.