COSETTE: New drug application for EVOXAC
COSETTE: New drug application for EVOXAC. Dated 20 days ago, it is in the active follow-up window. Score 85/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 7 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | COSETTE |
| Product | EVOXAC |
| Generic / ingredient | CEVIMELINE HYDROCHLORIDE |
| Approval | New drug application (NDA) |
| Application | NDA221183 |
| Decided | 2026-10-15 |
| Panel / class | SOLUTION, ORAL |
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| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-10-15
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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85 / 100 Score
- Decided in the last 30 days.
- A new product launch.
What is the FdaApprovalPulse record for COSETTE?
The FDA approved EVOXAC (NDA221183) for COSETTE on 2026-10-15: new drug application (NDA).
How does COSETTE compare to other FdaApprovalPulse records?
It is 20 days old, still within a typical 45-day follow-up window. Its Score of 85/100 puts it among the stronger signals in this feed.
COSETTE vs. top 3 peers
| Organization | Record date |
|---|---|
| COSETTE | 2026-10-15 |
| AVYXA HOLDINGS, LLC. | 2026-10-29 |
| GLAXOSMITHKLINE LLC | 2026-10-20 |
| FRESENIUS MEDCL CARE | 2026-10-19 |
Related records
FdaApprovalPulse: New drug application (NDA)
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