NDA 203109, held by Viatris. Sildenafil Citrate.
As of Nov 14, 2026, NDA 203109 (Revatio), held by Viatris, was first approved by FDA on Aug 30, 2012, with 13 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 4Efficacy (new indication or use) · Standard review | Approved | |
| Aug 30, 2012 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| RevatioEQ 10MG BASE/ML · for suspension;oral | Sildenafil Citrate | DiscontinuedReference drug |
| Oct 25, 2024 | Supplement 19Manufacturing | Approved | |
| Mar 3, 2023 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Feb 21, 2020 | Supplement 15Labeling · Standard review | Approved | |
| Jan 17, 2019 | Supplement 12Labeling · Standard review | Approved | |
| Jul 31, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Nov 22, 2016 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jun 4, 2015 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Apr 27, 2015 | Supplement 9Labeling · Standard review | Approved | |
| Jan 12, 2015 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Mar 11, 2014 | Supplement 2Labeling · Standard review | Approved | |
| Mar 6, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Jan 31, 2014 | Supplement 3Labeling · Standard review | Approved | |
| Jan 31, 2014 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Aug 30, 2012 | Original applicationNew dosage form · Priority 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
