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Competitive Generic Therapy Designations Growing Despite Lack Of Guidance

Executive Summary

US FDA developing document describing program operations, but that has not stopped sponsors from requesting and receiving the breakthrough-like designation. 

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US FDA’s First Competitive Generic Therapy Approval Comes With A Twist

Apotex’s potassium chloride oral solution is eligible for 180-day exclusivity under new expedited pathway even though Amneal’s generic referencing same product was approved three weeks earlier; Amneal's continued marketing will not be blocked by Apotex’s exclusivity, which is forfeited if it fails to launch within 75 days.

US FDA’s First Competitive Generic Therapy Approval Comes With A Twist

Apotex’s potassium chloride oral solution is eligible for 180-day exclusivity under new expedited pathway even though Amneal’s generic referencing same product was approved three weeks earlier; Amneal's continued marketing will not be blocked by Apotex’s exclusivity, which is forfeited if it fails to launch within 75 days.

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