1. Pink Sheet

Par Fights FDA Forfeiture Of Generic Colcrys Exclusivity

 
• By Brenda Sandburg

Pursing legal action against the agency in an area where it is sometimes vulnerable, Par argues that amending its proposed label did not interrupt paragraph IV certification for the firm's colchicine ANDA.

court house

Can an ANDA sponsor forfeit 180-day market exclusivity for its generic by amending its proposed label?

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Legal & IP

More from Pink Sheet