NDAORALTABLET, EXTENDED RELEASE
Approved
Apr 2008
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
1
Data completeness
6/8 — Strong
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APLENZIN is a bupropion hydrobromide extended-release tablet approved in April 2008 for treating major depressive disorder (MDD) and seasonal affective disorder (SAD). The drug works through presumed noradrenergic and dopaminergic mechanisms, acting as a weak inhibitor of neuronal reuptake of norepinephrine and dopamine without affecting serotonin or monoamine oxidase. APLENZIN represents an alternative salt formulation of bupropion designed to offer extended-release dosing for once-daily administration in patients requiring antidepressant therapy.
$0.0BPart D
2mo to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
Started Jun 2026
246 enrolled
Major Depressive Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.