NDA 22465, held by Novartis. Pazopanib Hydrochloride.
As of Nov 14, 2026, NDA 22465 (Votrient), held by Novartis, was first approved by FDA on Oct 19, 2009, with 28 approved supplements and 0 published complete response letters.
VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use: The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma VOTRIENT is indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma VOTRIENT is indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.
| Nov 18, 2014 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2012 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jan 12, 2012 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Oct 19, 2009 | Original applicationNew molecular entity | Approved |
| VotrientEQ 200MG BASE · tablet;oral | Pazopanib Hydrochloride | RxReference drug |
| VotrientEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pazopanib Hydrochloride | DiscontinuedReference drug |
| Jan 25, 2024 | Supplement 36Labeling · Standard review | Approved | |
| Dec 13, 2021 | Supplement 33Manufacturing | Approved | |
| Sep 22, 2021 | Supplement 32Labeling · Standard review | Approved | |
| Sep 22, 2021 | Supplement 31Labeling · Standard review | Approved | |
| Aug 17, 2020 | Supplement 29Labeling · Standard review | Approved | |
| Jul 17, 2020 | Supplement 30Labeling · Standard review | Approved | |
| Jun 2, 2020 | Supplement 28Labeling · Standard review | Approved | |
| May 31, 2017 | Supplement 25Labeling · Standard review | Approved | |
| May 31, 2017 | Supplement 24Labeling · Standard review | Approved | |
| Aug 5, 2016 | Supplement 23Labeling · Standard review | Approved | |
| May 20, 2016 | Supplement 22Labeling · Standard review | Approved | |
| Sep 22, 2015 | Supplement 21Labeling · Standard review | Approved | |
| Apr 1, 2015 | Supplement 20Labeling · Standard review | Approved | |
| Nov 18, 2014 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Jun 3, 2014 | Supplement 18Labeling · Standard review | Approved | |
| Nov 27, 2013 | Supplement 17Labeling · Standard review | Approved | |
| Aug 14, 2013 | Supplement 16Labeling · Standard review | Approved | |
| Aug 14, 2013 | Supplement 15Labeling · Standard review | Approved | |
| Aug 14, 2013 | Supplement 14Labeling · Standard review | Approved | |
| Nov 15, 2012 | Supplement 13Labeling · Standard review | Approved | |
| Apr 26, 2012 | Supplement 12Labeling · Standard review | Approved | |
| Apr 26, 2012 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Mar 20, 2012 | Supplement 11Labeling · Standard review | Approved | |
| Jan 12, 2012 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Oct 21, 2011 | Supplement 5Labeling | Approved | |
| Oct 21, 2011 | Supplement 3Labeling | Approved | |
| Apr 21, 2011 | Supplement 6REMS | Approved | |
| Apr 27, 2010 | Supplement 2Labeling | Approved | |
| Oct 19, 2009 | Original applicationNew molecular entity | 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
