Tuesday, 10 December 2019

Lupin receives FDA approval for Fluoxetine Tablets

13 February 2019 | News

It is the generic version of Alvogen’s Fluoxetine Tablets, 60mg

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).

Sign up for the editor pick and get articles like this delivered right to your inbox.

Editors Pick
+Country Code-Phone Number(xxx-xxxxxxx)


Comments

× Your session has been expired. Please click here to Sign-in or Sign-up
   New User? Create Account



Podcast

 

Survey Box

Is APAC region emerging as a leader in assistive technologies?

× Please select an option to participate in the poll.
Processing...   View poll results   More polls

× You have successfully cast your vote.
{{ optionDetail.option }}{{ optionDetail.percentage }}%
{{ optionDetail.percentage }}% Complete
More polls