FDA Stands By Generic "Shared Exclusivity" Policy During Paxil Appeal
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency will continue to award 180-day exclusivity to multiple ANDA filers "when applicable" while it appeals a ruling invalidating this approach for paroxetine generics. "Shared exclusivity" issues raised in the Paxil case could come up again if they are not resolved by the appeals court, FDA says.
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