NDC 69639-106
Akynzeo 260 mg per 20 mL / 0.28 mg per 20 mL injection
On the label: Helsinn Therapeutics (U.S.), Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| HAS Healthcare Advanced Synthesis SA | Biasca, Switzerland | Makes the active ingredient | No problems foundFeb 20, 2025 · 4 inspections |
| Helsinn Birex Pharmaceuticals Limited | Dublin, Ireland | Makes it and tests it | Problems found, fixed voluntarilyJul 15, 2022 · 6 inspections |
| Simtra Deutschland GmbH | Halle/Westfalen, Germany | Makes it and packages it | Serious problems, FDA actionSep 26, 2025 · 11 inspections, 1 with FDA action |
Product details
- Generic drug
- Fosnetupitant and Palonosetron: every company that makes it
- Form
- injection, intravenous
- Strength
- 260 mg per 20 mL / 0.28 mg per 20 mL
- Approval
- NDA NDA210493
- On the market since
- Aug 1, 2023
- Package NDCs
69639-106-01- Official label
- DailyMed (National Library of Medicine), updated Jun 23, 2026
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