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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...

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EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
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AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
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If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

Over The Counter: Driving Innovation In France’s Self-Care Market, With NèreS’ Luc Besançon

 
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Allergy Ingredient Itch Warning, ACNU Final Rule Scratch Extent Of FDA Authority For Label Changes

 
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Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.

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Senators’ Questions Stray Far From OMUFA During HELP Committee Hearing On Reauthorization

 
• By Malcolm Spicer

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu

People On The Move: Appointments At Klosterfrau, Haleon, Opella

 
• By Tom Gallen

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AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• By David Ridley

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos