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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.

The Food and Drug Administration’s 28 February approval of a new drug application for 125-mg ibuprofen and 250-mg acetaminophen tablet branded Advil Dual Action with Acetaminophen ended a busy month...

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More from Rx-to-OTC Switch

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Over The Counter: Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

 
• By David Ridley

HBW Insight finds out all about real world evidence and its potential for the OTC industry by chatting with IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer.

Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

More from Health

Self-Care Must Be Central To NHS Reform, Says UK Industry And Pharmacy Alliance

 
• By David Ridley

Ahead of a soon to be released 10-Year Health Plan for the English NHS, an alliance including PAGB calls for self-care to be “clearly recognised and supported through concrete policies that reflect its vital role in achieving the plan’s goals.”

OTC Marketing Awards 2025 Open For Entries

 
• By Tom Gallen

Find out how to enter the OTC Marketing Awards before the 1 September entry deadline.

Haleon Study: Boosting Health Literacy Could Save Major Economies Over $300bn Per Year

 
• By David Ridley

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.