FDA approved the original new drug application for OPTIMARK on December 8, 1999, sponsored by LIEBEL-FLARSHEIM. FDA classed that submission a new molecular entity, which makes it the first approval of gadoversetamide in any product. FDA marks all 4 products under the application discontinued. FDA has approved 2 efficacy supplements on the application since, the most recent on August 4, 2006.
- Application
- NDA020937
- Sponsor
- LIEBEL-FLARSHEIM
- Original approval
- Review
- standard review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- gadoversetamide
Browse every approval whose brand starts with O, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| gadoversetamide 4963.5MG/15ML (330.9MG/ML) | INJECTABLE | INJECTION | Discontinued |
| gadoversetamide 1654.5MG/5ML (330.9MG/ML) | INJECTABLE | INJECTION | Discontinued |
| gadoversetamide 6618MG/20ML (330.9MG/ML) | INJECTABLE | INJECTION | Discontinued |
| gadoversetamide 3309MG/10ML (330.9MG/ML) | INJECTABLE | INJECTION | Discontinued |
What “discontinued” means in FDA’s record
Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.
Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-3 | standard | |
| S-9 | — |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 9 · Manufacturing (CMC) 5. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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