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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?

That appears to be the question at the center of Par Pharmaceutical Inc.’s suit against FDA. The

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US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
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