Active substance
Levomilnacipran
- US FDA 5
- Health Canada 4
- US price lines 5
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FETZIMA | EQ 20MG BASE; EQ 40MG BASE; EQ 80MG BASE; EQ 120MG BASE | capsule, extended release · oral | ABBVIE | Prescription | 25 Jul 2013 |
| LEVOMILNACIPRAN HYDROCHLORIDE | EQ 20MG BASE; EQ 40MG BASE; EQ 80MG BASE; EQ 120MG BASE | capsule, extended release · oral | PRINSTON INC | Prescription | 20 Mar 2023 |
| LEVOMILNACIPRAN HYDROCHLORIDE | EQ 20MG BASE; EQ 40MG BASE; EQ 80MG BASE; EQ 120MG BASE | capsule, extended release · oral | AMNEAL PHARMS CO | Discontinued | 4 Feb 2019 |
| LEVOMILNACIPRAN HYDROCHLORIDE | EQ 20MG BASE; EQ 40MG BASE; EQ 80MG BASE; EQ 120MG BASE | capsule, extended release · oral | HIKMA PHARMS | Discontinued | 5 Nov 2020 |
| LEVOMILNACIPRAN HYDROCHLORIDE | EQ 20MG BASE; EQ 40MG BASE; EQ 80MG BASE; EQ 120MG BASE | capsule, extended release · oral | AUROBINDO PHARMA LTD | Discontinued | 6 Jan 2023 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| FETZIMA | 02440970 | 20 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | ABBVIE CORPORATION |
| FETZIMA | 02440989 | 40 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | ABBVIE CORPORATION |
| FETZIMA | 02440997 | 80 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | ABBVIE CORPORATION |
| FETZIMA | 02441004 | 120 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | ABBVIE CORPORATION |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | FETZIMA 20-40 MG TITRATION PAK | $17.60658 | per EA | 2 Jan 2026 |
| US NADAC | FETZIMA ER 120 MG CAPSULE | $17.58708 | per EA | 23 Sep 2026 |
| US NADAC | FETZIMA ER 20 MG CAPSULE | $17.59735 | per EA | 23 Sep 2026 |
| US NADAC | FETZIMA ER 40 MG CAPSULE | $17.61125 | per EA | 23 Sep 2026 |
| US NADAC | FETZIMA ER 80 MG CAPSULE | $17.5875 | 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 19 Apr 2024 FETZIMA — 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.