Competitive Generic Therapies Get Help With Development, But Not Goal Date
Draft guidance says US FDA will try to expedite assessment of competitive generic therapy designees, but will not give shorter review goals.
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Don't Assume Your ANDA Will Be Designated, US FDA Tells Aspiring Competitive Generic Therapy Sponsors
Final guidance clarifies that all sponsors who want CGT designation, which can bring exclusivity upon approval, should request it.
Lack Of Priority? No ANDAs Approved Using Expedited Pathway In FY 2018
US FDA also refused to receive many priority generic drug applications, suggesting the expedited pathway may not be working as intended quite yet.
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.