NDAORALCAPSULEPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
8
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Prozac (fluoxetine hydrochloride) is an oral small-molecule antidepressant approved in 1987 that treats depression and post-traumatic stress disorder. It works by inhibiting the neuronal reuptake of serotonin in the central nervous system, though its exact mechanism remains incompletely understood. This foundational SSRI established a therapeutic class that transformed psychiatric treatment.
LOE Approaching
As LOE approaches, the Prozac brand team is transitioning from growth-focused roles toward market defense and generic transition planning, with smaller team sizes expected.
Mechanism 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 (8)
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Under Fasting Condition
Started Feb 2006
54 enrolled
Healthy
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's Under Fed Condition
Started Feb 2006
54 enrolled
Healthy
90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions
Started May 2001
26 enrolled
Healthy
90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions
Started May 2001
26 enrolled
Healthy
To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg
Started Feb 2001
30 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.