Lupin unveils generic version of Prozac tablets in US
Fluoxetine tablet is a generic version of Eli Lilly and Company's Prozac tablets in the same strengths, Lupin said.
Mumba: Pharma major Lupin Limited (Lupin) recently announced the launch of generic antidepressant Fluoxetine tablets in the American market.
The company has launched Fluoxetine tablets USP in the strengths of 10 mg and 20 mg after having received an approval from the United States Food and Drug Administration (USFDA) earlier, Lupin said in a statement.
The product is a generic version of Eli Lilly and Company's Prozac tablets in the same strengths, it added.
The drug is used for the treatment of a major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder and bulimia nervosa, Lupin said.
It is indicated in the treatment of:
- Major Depressive Disorder (MDD)
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
- Obsessive-Compulsive Disorder (OCD)
Fluoxetine is indicated for 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 (OCD)
- Bulimia Nervosa
Fluoxetine is indicated for the acute and maintenance treatment of binge‑eating and vomiting behaviours in adult patients with moderate to severe Bulimia Nervosa.
- Panic Disorder
Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients.
Fluoxetine Tablets USP, 10 mg and 20 mg (RLD: Prozac®) had an annual sales of approximately USD 53 million in the US (IQVIA MAT June 2019). Based in Mumbai, Lupin's key focus areas include paediatrics, cardiovascular, anti-infectives, diabetology, asthma and anti-tuberculosis.