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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 proposing an order to remove oral phenylephrine from a monograph,...

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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."

More from Conferences

NAD Reviews ‘Made In USA’ Claim For Oral Care, Influencer Posts For Hair Brand Through Fast-Track SWIFT Program

 
• By Eileen Francis

The National Advertising Division of the BBB National Programs, Inc. closes two personal care ad claim challenges through its Fast-Track SWIFT Program in November, with the total number of assessments on that track in 2024 reaching 21.

APAC Congress: Regulators And Industry Agree ‘Bangkok Joint Initiative on Self-Care’

 
• By David Ridley

Organizations representing APAC health and medicines regulators and the consumer health industry respectively have agreed to “recognize the importance of self-care as a fundamental pillar of health and wellbeing” and “affirm our dedication to advancing self-care as an essential component of Universal Health Coverage.”

APAC Self-Care Congress: ‘Human Health Without Environmental Health Is Just Not Possible’

 
• By David Ridley

Self-care industry representatives from GSCF/AESGP, Bayer and Opella stress the seriousness of the global climate crisis at the 2024 GSCF, APSMI, TSMIA Joint Congress in Bangkok, Thailand, and also share iniatives that are attempting to deal with this crisis, for example replacing PVC in medicine blister packs with more easily recyclable materials.