isatuximab (isatuximab) by Sanofi-Aventis Deutschland GmbH: new drug for further processing listing
isatuximab (isatuximab) by Sanofi-Aventis Deutschland GmbH: new drug for further processing listing. Dated 119 days ago, it serves as a historical benchmark. Score 25/100. As of 2026-11-04, from U.S. FDA National Drug Code (NDC) Directory via openFDA.
Data as of · Compiled by Zalwin from U.S. FDA National Drug Code (NDC) Directory via openFDA
Free preview: all 9 published fields of this record are shown below. Locked: 106 related FdaNdcDirectoryPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Generic name | isatuximab |
| NDC | 12854-659 |
| Labeler | Sanofi-Aventis Deutschland GmbH |
| Product type | DRUG FOR FURTHER PROCESSING |
| Approval pathway | DRUG FOR FURTHER PROCESSING |
| Dosage form | INJECTION, SOLUTION, CONCENTRATE |
| Active ingredients | ISATUXIMAB 1400 mg/10mL |
| Marketing start | 2026-07-09 |
| Package configurations | 1 |
| Peer records CSV (107 records) | 🔒 Click to unlock → |
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- Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
- Record date: 2026-07-09
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA National Drug Code (NDC) Directory via openFDA · Last refreshed: Wed, 04 Nov 2026 18:12:05 GMT
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Peer benchmark and outreach value: isatuximab (isatuximab) by Sanofi-Aventis Deutschland GmbH and 107 DRUG FOR FURTHER PROCESSING peers
- DRUG FOR FURTHER PROCESSING FdaNdcDirectoryPulse records like this one: 107
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every DRUG FOR FURTHER PROCESSING peer: $21,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
25 / 100 Launch Signal Score
- Injectable: hospital and 503B relevance.
What is the FdaNdcDirectoryPulse record for isatuximab (isatuximab) by Sanofi-Aventis Deutschland GmbH?
isatuximab by Sanofi-Aventis Deutschland GmbH: new drug for further processing listing (DRUG FOR FURTHER PROCESSING) starting 2026-07-09.
How does isatuximab (isatuximab) by Sanofi-Aventis Deutschland GmbH compare to other FdaNdcDirectoryPulse records?
It is 119 days old; check the official source for later updates before acting. Its Launch Signal Score of 25/100 is modest; treat it as background rather than a priority.
isatuximab (isatuximab) by Sanofi-Aventis Deutschland GmbH vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| isatuximab (isatuximab) by Sanofi-Aventis Deutschland GmbH | DRUG FOR FURTHER PROCESSING | 2026-07-09 |
| Water (Water) by Siegfried Hameln GmbH | DRUG FOR FURTHER PROCESSING | 2026-10-19 |
| Donanemab (Donanemab) by BSP Pharmaceuticals S.p.A. | DRUG FOR FURTHER PROCESSING | 2026-09-22 |
| apitegromab (apitegromab) by Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | 2026-09-11 |
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Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.