METHADONE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 1947-08-13
- Routes
- ORAL, INJECTION, FOR RX COMPOUNDING
- Dosage Forms
- SOLUTION, TABLET, CONCENTRATE, INJECTABLE, TABLET, FOR SUSPENSION, POWDER
METHADONE HYDROCHLORIDE Approval History
What METHADONE HYDROCHLORIDE Treats
28 FDA approvalsOriginally approved for its first indication in 1947 . Covers 28 distinct patient populations.
- Other (28)
Other
(28 approvals)- • Approved indication (Aug 1947)
- • Approved indication (Dec 1947)
- • Approved indication (Mar 1973)
- • Approved indication (May 1981)
- • Approved indication (Aug 1982)
- • Approved indication (Mar 1983)
- • Approved indication (Nov 1994)
- • Approved indication (Apr 1995)
- • Approved indication (Mar 1998)
- • Approved indication (Apr 1998)Letter
- • Approved indication (May 1998)Letter
- • Approved indication (Apr 2004)
- • Approved indication (Jul 2005)
- • Approved indication (Nov 2009)
- • Approved indication (Jun 2010)
- • Approved indication (Aug 2015)
- • Approved indication (Aug 2015)
- • Approved indication (Oct 2017)Letter
- • Approved indication (Mar 2018)Letter
- • Approved indication (Aug 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Aug 2019)
- • Approved indication (Oct 2019)
- • Approved indication (Mar 2020)
- • Approved indication (Nov 2020)
- • Approved indication (Mar 2021)
- • Approved indication (Dec 2024)
- • Approved indication (May 2025) New
METHADONE HYDROCHLORIDE Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF METHADONE HYDROCHLORIDE INJECTION Addiction, Abuse, and Misuse Because the use of Methadone Hydrochloride Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions (see WARNINGS ). Life-Threatening Respiratory Depression Serious, life-thre...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF METHADONE HYDROCHLORIDE INJECTION Addiction, Abuse, and Misuse Because the use of Methadone Hydrochloride Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions (see WARNINGS ). Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Methadone Hydrochloride Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Methadone Hydrochloride Injection are essential (see WARNINGS ). Neonatal Opioid Withdrawal Syndrome (NOWS) Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of Methadone Hydrochloride Injection during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. The balance between the risks of NOWS and the benefits of maternal Methadone Hydrochloride Injection use may differ based on the risks associated with the mother’s underlying condition, pain, or addiction. Advise the patient of the risk of NOWS so that appropriate planning for management of the neonate can occur (see WARNINGS ). Managing Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Methadone Hydrochloride Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate (see WARNINGS , PRECAUTIONS ). Life-Threatening QT Prolongation QT interval prolongation and serious arrhythmia (torsades de pointes) hav
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
METHADONE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)1. Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use • Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration (see WARNINGS ), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be ...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF METHADONE HYDROCHLORIDE INJECTION Addiction, Abuse, and Misuse Because the use of Methadone Hydrochloride Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, asse...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.