NDAORALTABLET
Approved
May 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
3/8 — Basic
SARAFEM (fluoxetine hydrochloride) by Teva is unknown, it is presumed to be linked to its inhibition of cns neuronal uptake of serotonin. First approved in 2006.
Drug data last refreshed 1h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SARAFEM is a fluoxetine hydrochloride oral tablet approved by the FDA in 2006 for the treatment of premenstrual dysphoric disorder (PMDD). It is a selective serotonin reuptake inhibitor (SSRI) that works by inhibiting the CNS neuronal uptake of serotonin, thereby increasing serotonin availability in synaptic spaces.
LOE Approaching
With LOE approaching and moderate competitive pressure (30%), the SARAFEM team is likely consolidating operations and shifting focus toward post-LOE defense strategies rather than expansion.
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.