Lupin gets USFDA nod for depression drug

Pharma major Lupin announced that it has received approval for its Fluoxetine Tablets USP, 60mg.

Feb 12, 2019 10:02 IST India Infoline News Service

Pharma major Lupin announced on Tuesday that it has received approval from the United States Food and Drug Administration (FDA) to market a generic version of Alvogen's Fluoxetine Tablets, 60mg.

Despite the news, shares of the drug manufacturer closed 1% lower on the BSE.

Fluoxetine 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 $42.5mn in the US.

Lupin Ltd share price ended at Rs812.85, down Rs6.35, or 0.78%, from its previous close of Rs819.20 on the BSE. The scrip opened at Rs820 and touched a high and low of Rs824.50 and Rs808.90, respectively. A total of 17,64,880 (NSE+BSE) shares were traded on the counter. 

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