Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Par Fights FDA Forfeiture Of Generic Colcrys Exclusivity

Executive Summary

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.


Related Content

US FDA Gives Directions On Navigating Generic 180-Day Exclusivity Maze
FDA New Year’s Resolution: Guidances On Payor Communications, Biosimilarity
Takeda’s Take On Patent Certification Rules In Colchicine Dispute Rejected
Celebrex Generic Exclusivity Suit Could Have Broad Financial, Regulatory Reach
FDA Hit With Slew Of Suits As Firms Fight For Market Advantage


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts