NDA 22473, held by Viatris. Sildenafil Citrate.
As of Nov 15, 2026, NDA 22473 (Revatio), held by Viatris, was first approved by FDA on Nov 18, 2009, with 12 approved supplements and 0 published complete response letters.
Adults REVATIO is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. Pediatric Patients (1 to 17 Years Old) REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise.
| Mar 3, 2023 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jan 31, 2014 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Aug 30, 2012 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Nov 18, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| RevatioEQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) · solution;intravenous | Sildenafil Citrate | RxReference drug |
| Dec 16, 2024 | Supplement 19Manufacturing | Approved | |
| Mar 3, 2023 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jan 17, 2019 | Supplement 12Labeling · Standard review | Approved | |
| Jul 31, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Apr 27, 2015 | Supplement 10Labeling · Standard review | Approved | |
| Aug 21, 2014 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Mar 11, 2014 | Supplement 4Labeling · Standard review | Approved | |
| Mar 6, 2014 | Supplement 7Labeling · Standard review | Approved | |
| Jan 31, 2014 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jan 31, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Aug 30, 2012 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Nov 19, 2010 | Supplement 1Labeling | Approved | |
| Nov 18, 2009 | Original applicationNew dosage form · Standard review | Approved |
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
