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Potential Action By US FDA On Oral Phenylephrine ‘A Lot Harder’ With Old Monograph Program

 
• By Malcolm Spicer

“We've had several citizen petitions. We can't ignore the data that are out there and are very new since the last time FDA had looked at this back in 2007,” says FDA OTC drugs office director Theresa Michele.

• Source: Shutterstock

The US Food and Drug Administration is considering the efficacy of oral phenylephrine-containing nasal decongestants with regulatory tools it didn’t have when it asked the same question 16 years ago.

Those tools, delivered in the OTC monograph program overhaul authorized in 2020, make less difficult the agency’s process for potentially...

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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."

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