FDA approved the original new drug application for JESDUVROQ on February 1, 2023, sponsored by GLAXOSMITHKLINE. FDA classed that submission a new molecular entity, which makes it the first approval of daprodustat in any product. FDA marks all 5 products under the application discontinued. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA216951
- Sponsor
- GLAXOSMITHKLINE
- Original approval
- Review
- standard review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- daprodustat
Browse every approval whose brand starts with J, 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 |
|---|---|---|---|
| daprodustat 6MG | TABLET | ORAL | Discontinued |
| daprodustat 2MG | TABLET | ORAL | Discontinued |
| daprodustat 8MG | TABLET | ORAL | Discontinued |
| daprodustat 4MG | TABLET | ORAL | Discontinued |
| daprodustat 1MG | TABLET | ORAL | 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been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness.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.
FDA’s record shows no approved efficacy supplement on this application.
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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