Lupin gets FDA green light for generic Prozac
Lupin has received the Food and Drug Administration’s approval for its generic Prozac (fluoxetine tablets). Lupin's generic of the Eli Lilly drug was approved in 10-mg and 20-mg dosage strengths.
Fluoxetine is indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to 18 years; the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive-compulsive disorder; the acute and maintenance treatment of binge eating and vomiting behaviors in adult patients with moderate to severe bulimia nervosa; and the acute treatment of panic disorder, with or without agoraphobia, in adult patients.
Fluoxetine tablets, 10 mg and 20 mg, had a market value of roughly $68.2 million according to December 2018 IQVIA data.
Fluoxetine is indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to 18 years; the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive-compulsive disorder; the acute and maintenance treatment of binge eating and vomiting behaviors in adult patients with moderate to severe bulimia nervosa; and the acute treatment of panic disorder, with or without agoraphobia, in adult patients.
Fluoxetine tablets, 10 mg and 20 mg, had a market value of roughly $68.2 million according to December 2018 IQVIA data.