Active substance
Lubiprostone
- US FDA 7
- US price lines 4
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AMITIZA | 24MCG; 8MCG | capsule · oral | SUCAMPO PHARMA LLC | Prescription | 31 Jan 2006 |
| LUBIPROSTONE | 8MCG; 24MCG | capsule · oral | AMNEAL | Prescription | 30 Nov 2021 |
| LUBIPROSTONE | 8MCG; 24MCG | capsule · oral | TEVA PHARMS USA INC | Prescription | 18 Jan 2022 |
| LUBIPROSTONE | 8MCG; 24MCG | capsule · oral | DR REDDYS | Prescription | 8 Feb 2022 |
| LUBIPROSTONE | 8MCG; 24MCG | capsule · oral | ZYDUS PHARMS | Prescription | 23 Mar 2023 |
| LUBIPROSTONE | 8MCG; 24MCG | capsule · oral | ASCENT PHARMS INC | Prescription | 2 Jan 2025 |
| LUBIPROSTONE | 8MCG; 24MCG | capsule · oral | PH HEALTH | Discontinued | 27 Jun 2022 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | AMITIZA 24 MCG CAPSULE | $6.44889 | per EA | 22 Apr 2026 |
| US NADAC | AMITIZA 8 MCG CAPSULE | $6.46774 | per EA | 22 Apr 2026 |
| US NADAC | LUBIPROSTONE 24 MCG CAPSULE | $0.6507 | per EA | 23 Sep 2026 |
| US NADAC | LUBIPROSTONE 8 MCG CAPSULE | $0.56517 | 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 30 Nov 2020 AMITIZA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; 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.