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.
You may also be interested in...
Competitive Generic Therapy Designations Growing Despite Lack Of Guidance
US FDA developing document describing program operations, but that has not stopped sponsors from requesting and receiving the breakthrough-like designation.
Generic Industry Gets 267 Reasons From FDA To Pursue ANDA Development
US agency’s list of off-patent, off-exclusivity drugs that lack generic versions is aimed at improving transparency and encouraging competition, but almost half the 267 listed products involve complex issues that would require further decision-making by FDA ahead of ANDA submission.
Breakthrough-Style Program For ANDAs Added To House User Fee Bill
Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.