Fanaptum Vanda Pharmaceuticals Ltd · Application withdrawn · ATC N05AX14
Therapeutic indication (EMA)
treatment of schizophrenia
Active substance
Iloperidone
- US FDA 4
- EMA 3
- US price lines 7
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FANAPT | 1MG; 2MG; 4MG; 6MG; 8MG; 10MG; 12MG | tablet · oral | VANDA PHARMS INC | Prescription | 6 May 2009 |
| ILOPERIDONE | 1MG; 2MG; 4MG; 6MG; 8MG; 10MG; 12MG | tablet · oral | ADAPTIS | Discontinued | 28 Nov 2016 |
| ILOPERIDONE | 1MG; 2MG; 4MG; 6MG; 8MG; 10MG; 12MG | tablet · oral | TARO | Discontinued | 22 Jul 2019 |
| ILOPERIDONE | 1MG; 2MG; 4MG; 6MG; 8MG; 10MG; 12MG | tablet · oral | LUPIN | Discontinued | 5 May 2022 |
EMA European Union — centrally authorised medicines
Fanaptum Vanda Pharmaceuticals Ltd · Refused · ATC N05AX14
Therapeutic indication (EMA)
Treatment of schizophrenia
Iloperidone Vanda Pharmaceuticals Vanda Pharmaceuticals Netherlands B.V. · Refused · ATC N05AX14
Therapeutic indication (EMA)
Iloperidone is indicated for: treatment of schizophrenia in adults acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | FANAPT 1 MG TABLET | $30.49846 | per EA | 23 Sep 2026 |
| US NADAC | FANAPT 10 MG TABLET | $60.28658 | per EA | 23 Sep 2026 |
| US NADAC | FANAPT 12 MG TABLET | $60.00994 | per EA | 23 Sep 2026 |
| US NADAC | FANAPT 2 MG TABLET | $30.73767 | per EA | 23 Sep 2026 |
| US NADAC | FANAPT 4 MG TABLET | $30.53019 | per EA | 23 Sep 2026 |
| US NADAC | FANAPT 6 MG TABLET | $37.61441 | per EA | 23 Sep 2026 |
| US NADAC | FANAPT 8 MG TABLET | $37.4823 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 22 Jan 2025 FANAPT — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.