Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 217379
Company: CYCLE
Company: CYCLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAVHANZA | NILOTINIB | 60MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | No |
| CAVHANZA | NILOTINIB | 80MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/29/2026 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217379Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2026 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217379s002lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/29/2026 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217379s002lbl.pdf |