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Paxil ANDAs From Alphapharm, Sandoz Receive Final Approval From FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

TorPharm's exclusivity for paroxetine (GlaxoSmithKline's Paxil) comes to an end. FDA had tentatively approved both Alphapharm's and Sandoz' ANDAs.

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FDA Stands By Generic "Shared Exclusivity" Policy During Paxil Appeal

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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