Used in scans for disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions). NDA 20131, held by Bracco. Gadoteridol.
As of Nov 13, 2026, NDA 20131 (Prohance), held by Bracco, was first approved by FDA on Nov 16, 1992, with 28 approved supplements and 0 published complete response letters.
ProHance is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates lesions in the head and neck in adults 1.1 MRI of the Central Nervous System (CNS) ProHance is indicated for magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2020 | Supplement 35Efficacy (new indication or use) · Standard review | Approved | |
| Nov 21, 1994 | Supplement 2Efficacy (new indication or use) | Approved | None posted |
| Nov 21, 1994 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Nov 16, 1992 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prohance279.3MG/ML · injectable;injection | Gadoteridol | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 5, 2025 | Supplement 44Labeling · Standard review | Approved | |
| Aug 14, 2024 | Supplement 42Labeling · Standard review | Approved | |
| Jul 23, 2024 | Supplement 43Labeling · Standard review | Approved | |
| Jan 26, 2024 | Supplement 40Labeling · Standard review | Approved | |
| Nov 28, 2022 | Supplement 37Labeling · Standard review | Approved | |
| Dec 19, 2020 | Supplement 35Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2018 | Supplement 28Labeling · Standard review | Approved | |
| Sep 15, 2017 | Supplement 27Labeling · Standard review | Approved | |
| Aug 13, 2013 | Supplement 26Labeling · Standard review | Approved | |
| Dec 20, 2010 | Supplement 24Labeling | Approved | |
| Sep 4, 2007 | Supplement 23Labeling · Standard review | Approved | |
| Sep 30, 2002 | Supplement 16Labeling · Standard review | Approved | |
| Sep 30, 2002 | Supplement 9Labeling · Standard review | Approved | |
| Jun 3, 2002 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jul 19, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Mar 9, 2001 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jan 24, 2001 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 2, 1998 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1997 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1997 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1997 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 29, 1997 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Oct 8, 1996 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1996 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 8, 1995 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 21, 1994 | Supplement 2Efficacy (new indication or use) | Approved | None posted |
| Nov 21, 1994 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Oct 26, 1993 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 16, 1992 | Original applicationNew molecular entity · Standard review | Approved | None posted |
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
