FDA — authorised 5 January 2024
- Application: ANDA203640
- Marketing authorisation holder: APOTEX
- Local brand name: NILOTINIB HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Nilotinib Hydrochloride in United States
FDA authorised Nilotinib Hydrochloride on 5 January 2024 · 380 US adverse-event reports
Marketing authorisations
FDA — authorised 19 November 2025
- Application: ANDA209651
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: NILOTINIB HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 November 2025
- Application: ANDA218350
- Marketing authorisation holder: DR REDDYS
- Local brand name: NILOTINIB HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 November 2025
- Application: ANDA218544
- Marketing authorisation holder: MSN
- Local brand name: NILOTINIB HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 December 2025
- Application: ANDA218532
- Marketing authorisation holder: TORRENT
- Local brand name: NILOTINIB HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 380
Most-reported reactions
- Pruritus — 43 reports (11.32%)
- Abdominal Pain — 41 reports (10.79%)
- Fatigue — 41 reports (10.79%)
- Dyspnoea — 40 reports (10.53%)
- Arthralgia — 39 reports (10.26%)
- Nausea — 39 reports (10.26%)
- Dizziness — 37 reports (9.74%)
- Diarrhoea — 34 reports (8.95%)
- Chills — 33 reports (8.68%)
- Fall — 33 reports (8.68%)
Nilotinib Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Nilotinib Hydrochloride approved in United States?
Yes. FDA authorised it on 5 January 2024; FDA authorised it on 19 November 2025; FDA authorised it on 19 November 2025.
Who is the marketing authorisation holder for Nilotinib Hydrochloride in United States?
APOTEX holds the US marketing authorisation.