1. Generics Bulletin

Breckenridge Eyes First Kyprolis Generic With FDA Approval

US Firm Received ANDA Approval With Partner Natco

 
• By Dean Rudge

Towa’s US-based Breckenridge is aiming for exclusivity with its generic version of Amgen’s Kyprolis – developed with partner Natco Pharma – after obtaining one of the first approvals for several strengths of the treatment for relapsed or refractory multiple myeloma.

Entrance to FDA headquarters in Maryland
FDA approval follows a 2019 settlement deal • Source: Shutterstock

Breckenridge Pharmaceutical Inc. and partner Natco Pharma Limited are in pole position to be among the first US generic entrants for Amgen’s Kyprolis (carfilzomib) after Breckenridge received US Food and Drug Administration approval for its abbreviated new drug application.

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 Products

More from Generics Bulletin