Active substance
Metaxalone
- US FDA 10
- US price lines 2
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| METAXALONE | 800MG | tablet · oral | SANDOZ | Prescription | 31 Mar 2010 |
| METAXALONE | 800MG | tablet · oral | AMNEAL PHARMS | Prescription | 21 Jun 2013 |
| METAXALONE | 400MG | tablet · oral | MOUNTAIN | Prescription | 27 Feb 2015 |
| METAXALONE | 640MG | tablet · oral | PRIMUS PHARMS | Prescription | 1 Jun 2015 |
| METAXALONE | 800MG | tablet · oral | LANNETT CO INC | Prescription | 22 Nov 2016 |
| METAXALONE | 800MG | tablet · oral | ACTAVIS LABS FL INC | Prescription | 15 Jun 2017 |
| METAXALONE | 800MG; 400MG | tablet · oral | SCIEGEN PHARMS | Prescription | 31 Aug 2017 |
| SKELAXIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | KING PHARMS | Discontinued | 13 Aug 1962 |
| METAXALONE | 800MG | tablet · oral | RISING | Discontinued | 24 Sep 2018 |
| METAXALONE | 800MG | tablet · oral | INGENUS PHARMS LLC | Discontinued | 21 Oct 2020 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | METAXALONE 400 MG TABLET | $2.59291 | per EA | 23 Sep 2026 |
| US NADAC | METAXALONE 800 MG TABLET | $0.45237 | 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 21 Jun 2024 SKELAXIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions - US FDA 10 Jan 2024 METAXALONE — safety-related labeling change
Labeling sections changed: 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.