NDAORALTABLET
Approved
Oct 2011
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
FLUOXETINE HYDROCHLORIDE (fluoxetine hcl) by Lavipharm is unknown, it is presumed to be linked to its inhibition of cns neuronal uptake of serotonin. First approved in 2011.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fluoxetine HCl is an oral tablet formulation of fluoxetine, a selective serotonin reuptake inhibitor (SSRI) approved in 2011 by NDA. It is presumed to work by inhibiting CNS neuronal uptake of serotonin, though the exact mechanism remains not fully elucidated. Fluoxetine treats depression and related psychiatric conditions in adult and pediatric patients.
Peak
Product is at peak lifecycle maturity with established market presence; commercial teams are focused on defending market share against 30% competitive pressure rather than growth initiatives.
Mechanism of Action
unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
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.