Ranbaxy Slated For Generic Nexium Approval

U.S. FDA Feb. 7 granted Ranbaxy a tentative approval for 20 mg and 40 mg delayed-release capsules of esomeprazole, a generic version of AstraZeneca's Nexium. The proton pump inhibitor is scheduled to lose U.S. exclusivity in October 2009. AstraZeneca reported $3.4 billion in U.S. Nexium sales for 2007. Gurgaon, India-based Ranbaxy claims it has first-to-file status for esomeprazole, which would give the company 180-day marketing exclusivity

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Archive

More from Scrip

KalVista’s Delayed FDA Approval In HAE Comes Through

 
• By 

KalVista’s Ekterly obtains US approval as the first oral, on-demand therapy for hereditary angioedema. It will compete with established injectables.

Cogent Peaks With Bezaclastinib SUMMIT Results

 

The biotech announced positive topline results from the Phase II SUMMIT study in non-advanced systemic mastocytosis, with data for advanced SM and GIST expected later this year.

France’s AB Science Plots Pivotal Masitinib Trial In Prostate Cancer

 
• By 

Still holding out hope after multiple rejections for the tyrosine kinase inhibitor.