1. Generics Bulletin
  2. >>Archive

Norwich Falls To FDA, Bausch, In Bid For Final US Rifaximin Approval

Federal Court In DC Ruling Adds Another Twist In ‘Skinny Label’ ANDA Saga

 
• By Dean Rudge

Norwich brought suit against the US Food and Drug Administration in its bid to get final approval for its Xifaxan ANDA product with patent-protected indications carved out, following an earlier patent-infringement decision. Now, a court in Washington DC has had its say.

Denied red stamp with pen signature
• Source: Shutterstock

Norwich Pharmaceuticals had already failed once in its bid to get around an unfavorable US patent-infringement ruling over Bausch Health’s Xifaxan (rifaximin) which has put the brakes on final abbreviated new drug application approval until relative patents expire in October 2029.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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 Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Generics Bulletin, or if you love it how it is, now is the time to have your voice heard.

Is Towa’s Guidance For 2024 ‘Somewhat Mediocre?’

 
• By Dean Rudge

Bringing in sales that translated to nearly $1.5bn last year, Japan’s Towa was feeling upbeat after a challenging few years, both for itself and the broader Japanese generics market. However, its financial guide for the next 12 months has left investors feeling cold.

Publisher’s Spotlight: Citeline News And Insights App

 
• By Generics Bulletin Team

Introducing the all-new Citeline News and Insights app, providing seamless access to all your favorite award-winning publications. Explore the latest articles from Pink Sheet, Scrip, In Vivo, Medtech Insight, Generics Bulletin and HBW Insight, all in one stylish, intuitive and user-friendly platform.

More from Generics Bulletin

Xbrane Approves Deal Giving Away Cimzia Rival To Alvotech

 
• By Adam Zamecnik

After announcing the agreement last month, Xbrane has now approved its deal with Alvotech as part of an extra general meeting.

Celltrion Celebrates Interchangeability Designation For Humira Biosimilar In The US

 
• By Urtė Fultinavičiūtė

Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.

Samsung Bioepis Reevaluating Approach To Biosimilars

 
• By Jessica Merrill

The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.