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US OTC Internal Analgesic Monograph Includes Gelcap Format, Rapid Release Indication – Court

 
• By Malcolm Spicer

Putative class-action complaint alleging false advertising for Tylenol Rapid Release gelcaps recently dismissed on J&J Consumer’s motion arguing that federal preemption prohibits requiring different or additional labeling for drugs available under FDA OTC monograph.

• Source: Shutterstock

A federal judge rejects a class action plaintiff’s parsing of a US Food and Drug Administration OTC monograph to exclude the gelcap format and a rapid release indication and to negate federal preemption of challenging a claim for a Tylenol internal analgesic formulation.

A putative class-action complaint filed against Johnson & Johnson Consumer Inc. in US District Court for Massachusetts in July...

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More from International

IQVIA Consumer Health: Digestive Category Driving Global OTC Market Growth

 
• By David Ridley

An increasing awareness of and interest in gut health helped the global OTC market grow by 4.6% in value terms in 2024, according to IQVIA Consumer Health.

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.

Stada Expands Oilatum Range To Meet Saudi Arabia’s Skin-Care Needs

 
• By David Ridley

Stada launches nine new Oilatum products in Saudi Arabia including “rich moisturising creams for intense hydration, gentle body washes for daily cleansing, and baby-specific products like soothing bath bubbles and head-to-toe wash.”

Bayer And GSCF Paper Outlines ‘Practical Actions’ For Scaling Self-Care Globally

 
• By David Ridley

Bayer Consumer Health, the Global Self-Care Federation and the Business Council for International Understanding outline in a paper how industry can work with multilateral organizations, governments, financial institutions, and stakeholders to "recognize and champion self-care as a fundamental driver of global health progress."

More from Geography

Haleon Study: Self-Care Policies Could Save Finland €60m Per Year

 
• By David Ridley

Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.

PAGB: UK Gov Must Invest In Self-Care To Realize ‘Untapped Potential’

 
• By David Ridley

Reacting to chancellor Rachel Reeves' 2025 public spending review, PAGB welcomed increased funding for healthcare and life sciences while stressing the need to promote self-care practices.

German Associations Call For EU Green Claims Directive Trilogue Suspension

 
• By David Ridley

Pharma Deutschland is one of 21 German associations calling for trilogue negotiations in relation to the EU Green Claims Directive to be suspended while a “comprehensive and independent written impact assessment” is undertaken.