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23 May, 2019 16:35 IST
Lupin receives FDA approval for Fluoxetine Tablets
Source: IRIS | 12 Feb, 2019, 04.32PM
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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 (MOD).

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).

Shares of the company declined Rs 11.2, or 1.35%, to settle at Rs 819.20. The total volume of shares traded was 91,843 at the BSE (Monday).



Lupin Limited   (Q,N,C,F)*

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