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As of Nov 14, 2026, NDA 21779 (Ventavis), held by Actelion, was first approved by FDA on Dec 29, 2004, with 15 approved supplements and 0 published complete response letters.
First approved: Dec 29, 2004
Review: Priority
Supplements approved: 15
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 16 submissions below
Aug 24, 2005
Supplement 1Efficacy (new indication or use) · Standard review
Ventavis20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;inhalation
Ventavis10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;inhalation
Ventavis20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;inhalation
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
