Pharma major Lupin announced that it has received approval for its Fluoxetine Tablets USP, 60mg, from the United States Food and Drug Administration (FDA) to market a generic version of Alvogen’s Fluoxetine Tablets, 60mg.
Lupin’s Fluoxetine Tablets USP, 60mg, is the generic version of Alvogen’s Fluoxetine Tablets, 60mg. It is indicated in the treatment of:
Major Depressive Disorder (MDD)
Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study.
Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age.
Obsessive Compulsive Disorder (OCD)
Adults: Efficacy was established in two 13-week trials.
Pediatrics: Efficacy was established in one 13-week trial in pediatric patients 7 to 17 years of age.
Bulimia Nervosa
Adults: Efficacy was established in two 8-week trials and one 16-week trial.
Panic disorder, with or without agoraphobia
Adults: Efficacy was established in two 12-week trials.
Fluoxetine Tablets, 60mg, had annual sales of approximately USD 42.5 million in the US (IQVIA MAT December 2018).
