Active substance
Alosetron
- US FDA 7
- US price lines 2
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LOTRONEX | EQ 1MG BASE; EQ 0.5MG BASE | tablet · oral | LEGACY | Prescription | 9 Feb 2000 |
| ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE; EQ 1MG BASE | tablet · oral | AMNEAL PHARMS | Prescription | 22 Dec 2016 |
| ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE; EQ 1MG BASE | tablet · oral | RISING | Prescription | 14 Jan 2019 |
| ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE; EQ 1MG BASE | tablet · oral | ADAPTIS | Prescription | 16 Sep 2019 |
| ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE; EQ 1MG BASE | tablet · oral | MANKIND PHARMA | Prescription | 9 Sep 2020 |
| ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE; EQ 1MG BASE | tablet · oral | HIKMA PHARMS | Discontinued | 4 May 2015 |
| ALOSETRON HYDROCHLORIDE | EQ 0.5MG BASE; EQ 1MG BASE | tablet · oral | PH HEALTH | Discontinued | 23 Feb 2018 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ALOSETRON HCL 0.5 MG TABLET | $2.01861 | per EA | 23 Sep 2026 |
| US NADAC | ALOSETRON HCL 1 MG TABLET | $3.41983 | 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 3 Apr 2019 LOTRONEX — safety-related labeling change
Labeling sections changed: Boxed Warning; 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.