Lupin launches Fluoxetine Tablets USP

Lupin Limited (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.
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 41 million in the US (IQVIA MAT February 2019).

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