COTEMPLA XR-ODT
Details
- Status
- Prescription
- First Approved
- 2017-06-19
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
COTEMPLA XR-ODT Approval History
What COTEMPLA XR-ODT Treats
1 indicationsCOTEMPLA XR-ODT is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention Deficit Hyperactivity Disorder
COTEMPLA XR-ODT Boxed Warning
ABUSE, MISUSE, AND ADDICTION COTEMPLA XR-ODT 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 COTEMPLA XR-ODT, can result in overdose and death (5.1, 9.2, 10). Before prescribing COTEMPLA XR-ODT, 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 dr...
WARNING: ABUSE, MISUSE, AND ADDICTION COTEMPLA XR-ODT 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 COTEMPLA XR-ODT, can result in overdose and death (5.1, 9.2, 10). Before prescribing COTEMPLA XR-ODT, 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 treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. COTEMPLA XR-ODT 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 COTEMPLA XR-ODT, can result in overdose and death (5.1, 9.2, 10): • Before prescribing COTEMPLA XR-ODT, 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 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.
COTEMPLA XR-ODT FDA Label Details
ProIndications & Usage
FDA Label (PDF)COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see Clinical Studies ]. Limitations of Use The use of COTEMPLA XR-ODT is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions . Use in Specific Populations ] . COTEMPLA XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention...
WARNING: ABUSE, MISUSE, AND ADDICTION COTEMPLA XR-ODT 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 COTEMPLA XR-ODT, can result in overdose and death (5.1, 9.2, 10). Before ...
COTEMPLA XR-ODT Patents & Exclusivity
Patents (48 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.