CYCLE: New drug application for CAVHANZA
CYCLE: New drug application for CAVHANZA. Dated 159 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-03, 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 | CYCLE |
| Product | CAVHANZA |
| Generic / ingredient | NILOTINIB |
| Approval | New drug application (NDA) |
| Application | NDA217379 |
| Decided | 2026-05-29 |
| Panel / class | TABLET, ORALLY DISINTEGRATING, ORAL |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| 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: 2026-05-29
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 05:14:00 GMT
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55 / 100 Score
- A new product launch.
What is the FdaApprovalPulse record for CYCLE?
The FDA approved CAVHANZA (NDA217379) for CYCLE on 2026-05-29: new drug application (NDA).
How does CYCLE compare to other FdaApprovalPulse records?
It is 159 days old; check the official source for later updates before acting.
CYCLE vs. top 3 peers
| Organization | Record date |
|---|---|
| CYCLE | 2026-05-29 |
| GLAXOSMITHKLINE LLC | 2026-10-20 |
| FRESENIUS MEDCL CARE | 2026-10-19 |
| FRESENIUS MEDCL CARE | 2026-10-19 |
Related records
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.