Cavhanza (nilotinib)
New formulation or manufacturer
- Region
- 🇺🇸 US
- Active substance
- nilotinib
- Company
- Cycle
- Status
- Approved
- FDA approval
- Fri 29 May 2026
- Designations
- New formulation or manufacturer
- Application
- NDA217379
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 29 May 2026🇺🇸 FDA approval
FDA approves Cavhanza (nilotinib): new formulation or manufacturer
Cycle; NDA217379; New formulation or manufacturer; tablet, orally disintegrating · source
Same substance in other markets
- 🇪🇺 Tasigna Authorised · Novartis Europharm Limited
- 🇪🇺 Nilotinib Accord Authorised · Accord Healthcare S.L.U.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.