METHAMPHETAMINE HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 1976-01-19
- Routes
- ORAL
- Dosage Forms
- TABLET
METHAMPHETAMINE HYDROCHLORIDE Approval History
What METHAMPHETAMINE HYDROCHLORIDE Treats
1 indicationsMETHAMPHETAMINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention Deficit Hyperactivity Disorder
METHAMPHETAMINE HYDROCHLORIDE Boxed Warning
Methamphetamine has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methamphetamine, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing methamphetamine, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and ...
Methamphetamine has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methamphetamine, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing methamphetamine, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout methamphetamine treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ) and Drug Abuse and Dependence ( 9.2 )] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. Methamphetamine has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methamphetamine, can result in overdose and death. ( 5.1 , 9.2 , 10 ): • Before prescribing methamphetamine hydrochloride tablets, assess each patient’s risk for abuse, misuse, and addiction. • Educate patients and their families about these risks, proper storage of each drug, and proper disposal of any unused drug. • Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
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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.
METHAMPHETAMINE HYDROCHLORIDE FDA Label Details
ProIndications & Usage
Methamphetamine hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older. • Methamphetamine hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older.
Methamphetamine has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methamphetamine, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with hig...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.