fluoxetine hcl

1 INDICATIONS AND USAGE Fluoxetine tablets are indicated for the treatment of: • Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies ( 14.1 )] . • Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies ( 14.2 )] . • Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies ( 14.3 )] . • Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies ( 14.4 )] . Fluoxetine tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: • Major Depressive Disorder (MDD) ( 1 ) • Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study ( 14.1 ) • Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age ( 14.1 ) • Obsessive Compulsive Disorder (OCD) ( 1 ) • Adults: Efficacy was established in two 13-week trials ( 14.2 ) • Pediatrics: Efficacy was established in one 13-week trial in patients 7 to 17 years of age ( 14.2 ) • Bulimia Nervosa ( 1 ) • Adults: Efficacy was established in two 8-week trials and one 16-week trial ( 14.3 ) • Panic Disorder, with or without agoraphobia ( 1 ) • Adults: Efficacy was established in two 12-week trials ( 14.4 )