NDAORALCAPSULEPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
9
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 16h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Prozac (fluoxetine hydrochloride) is an oral selective serotonin reuptake inhibitor (SSRI) approved in 1987 for depression, anxiety disorders, OCD, and bulimia. It works by increasing serotonin availability in the central nervous system to improve mood and reduce compulsive behaviors. Fluoxetine is one of the most widely prescribed antidepressants globally and remains a foundational treatment in psychiatry.
LOE Approaching
Prozac is in advanced lifecycle maturity with moderate competitive pressure (45/100), suggesting a stable but defensive commercial environment with focus on retention and cost-efficiency.
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 (9)
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Under Fasting Condition
Started Feb 2006
54 enrolled
Healthy
Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg
Started Feb 2006
32 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
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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.