PROZAC
LOE ApproachingNDAORALTABLET
Approved
Mar 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
5/8 — Partial
PROZAC by Eli Lilly and Company is unknown, it is presumed to be linked to its inhibition of cns neuronal uptake of serotonin. Approved for depressive episodes associated with bipolar i disorder, the treatment of treatment resistant depression. First approved in 1999.
Drug data last refreshed 2d ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROZAC (fluoxetine hydrochloride) is an oral small-molecule tablet approved by the FDA on March 9, 1999, for the treatment of depressive episodes associated with Bipolar I Disorder and treatment-resistant depression. The drug is presumed to work through inhibition of CNS neuronal uptake of serotonin, though its exact mechanism of action remains incompletely understood. As a selective serotonin reuptake inhibitor (SSRI), it represents a foundational pharmacotherapy in psychiatric treatment and remains widely prescribed despite the emergence of newer alternatives.
$0.0BPart D
Mechanism of Action
unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
Clinical Trials (2)
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions
Started Jun 1996
46 enrolled
Depression
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions
Started May 1996
24 enrolled
Depression
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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.