Express Pharma

Lupin launches Fluoxetine tabs

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The drug is indicated in the treatment of major depressive disorder, obsessive compulsive disorder, bulimia nervosa

Lupin announced the launch of Fluoxetine Tablets USP, 60mg, having received an approval from the United States Food and Drug Administration (FDA) earlier.

Lupin’s Fluoxetine Tablets USP, 60mg, is the generic version of Alvogen Group Holdings 3 LLC’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
Paediatrics: 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
Paediatrics: Efficacy was established in one 13-week trial in paediatric 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 $41 million in the US (IQVIA MAT February 2019).

 

 

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