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US FDA Suggests Adding Antioxidants To Drug Formulations To Mitigate Nitrosamine Risks

 
• By Malcolm Spicer

Agency recommends “mitigation strategies” also including designing formulations that incorporate excipients such as sodium carbonate which modify the micro-environment to neutral or basic pH.

• Source: Alamy

The US Food and Drug Administration is suggesting drug formulation options intended to inhibit the development of potentially carcinogenic nitrosamines, a problem first found in OTC heartburn remedies containing ranitidine.

The options, called “mitigation strategies” in an update the agency published on 22 November, include adding antioxidants such as vitamin...

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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

Self-Testing Kits Need To Be Regulated Like OTCs, UK Researchers Argue

 
• By David Ridley

Concerns raised by two recent studies prompt UK researchers to argue for greater regulation with regards to direct-to-consumer test kits.

Urban Wastewater Directive: AESGP Requests Intervention In EFPIA’s Legal Action

 
• By David Ridley

AESGP has formally submitted a request to the General Court of the European Union to intervene in the European Federation of Pharmaceutical Industries and Association’s legal action against the revised EU Urban Wastewater Directive.

Over The Counter: Seizing The Healthy Aging Opportunity, With Prime Fifty’s Max Gowland

 
• By David Ridley

HBW Insight speaks to Prime Fifty founder and managing director Max Gowland about the science behind healthy aging and the opportunity for the consumer health industry.