1. HBW Insight
  2. >>Geography
  3. >>International

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

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 Conferences

AESGP Annual Meeting: Wastewater Directive Impact Assessment ‘Fundamentally Flawed’

 
• By David Ridley

AESGP president Jonathan Workman opens the 61st Annual Meeting with calls for industry unity in the face of the problematic revised EU Urban Wastewater Treatment Directive.

Cosmetics Industry: Push Congress To Apply Pressure On MoCRA – Attorney

 
• By Eileen Francis

The US cosmetics industry, particularly small- and medium-sized businesses, should reach out to their representatives in Congress to encourage pressure on the US Food and Drug Administration to implement cosmetics reform, despite agency staff cuts.

EU Sunscreen Stakeholder Group Pushing For Legally Binding Text For Sun Protection

 
• By Eileen Francis

Personal care, EU government reps discussing a planned revision of the 2006 European Union Suncare Recommendation are pushing for a legally binding text, rather than the recommendation, and considering broadening the definition for sunscreen.