NDAORALCAPSULEPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Mechanism of Action
unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
Clinical Trials (5)
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
Does Fluoxetine Have an Effect on the CNS CRF Systems in Women Abused in Childhood?
Started Dec 1997
80 enrolled
Major Depressive Disorder
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