US Zantac Sales And Distribution Continue As Sanofi Tests For NDMA

Novartis, which licensed OTC Zantac for US marketing to Sanofi, stops distribution of the histamine-2 blocker ranitidine to presence of NDMA, a probable carcinogen. Decision doesn’t affect US sales of OTC Zantac in US, where FDA says NDMA found in ingredient is at low levels.

Map of USA with a red pushpin stuck - Image

Sanofi plans to continue distributing Zantac OTC heartburn remedy in the US while the firm conducts its own tests to determine whether levels of N-nitrosodimethylamine (NDMA) in the active ingredient ranitidine are above safe levels.

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

More from Regulation

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
• By 

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By 

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.

Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

More from Policy & Regulation

EU Parliament Agrees To Postpone Due Diligence And Sustainability Reporting Rules

 
• By 

Speaking at a recent AESGP webinar, sustainability expert Onur Durmus called the the European Commission’s “Omnibus” proposals - designed to simplify ESG reporting rules and recently supported by EU Parliament - a “positive development” for the European consumer health industry.

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By 

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.

Doctors In The House: Sunscreen Innovation Diagnoses From Health Subcommittee

 

Energy and Commerce Health Subcommittee members, including several health care professionals, make clear their concerns about the US sunscreen market during hearing on reauthorizing FDA’s OMUFA program.