Lupin gets FDA green light for generic Prozac

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Lupin gets FDA green light for generic Prozac

By Sandra Levy - 04/16/2019
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.

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