Active substance
Alvimopan
- US FDA 4
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ALVIMOPAN | 12MG | capsule · oral | WATSON LABS TEVA | Prescription | 19 Dec 2019 |
| ALVIMOPAN | 12MG | capsule · oral | PH HEALTH | Prescription | 24 Jan 2023 |
| ALVIMOPAN | 12MG | capsule · oral | HIKMA PHARMS | Prescription | 31 Aug 2023 |
| ENTEREG | 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule · oral | CUBIST PHARMS | Discontinued | 20 May 2008 |
Safety signals and safety-related labeling changes
- US FDA 17 Nov 2020 ENTEREG — safety-related labeling change
Labeling sections changed: Boxed Warning; 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.