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):
Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study.
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.
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.