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Lupin receives FDA approval for Fluoxetine Tablets USP
Mumbai, Baltimore, April 16, 2019: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Fluoxetine Tablets USP, 10 mg and 20 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s (Eli Lilly) Prozac Tablets, 10 mg and 20 mg.
Lupin’s Fluoxetine Tablets USP, 10 mg and 20 mg, is the generic version of Eli Lilly’s Prozac Tablets, 10 mg and 20 mg. 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)
Fluoxetine is indicated for the acute and maintenance treatment of binge eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa.
Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients.
Fluoxetine Tablets, 10 mg and 20 mg, (RLD: Prozac) had annual sales of approximately USD 68.2 million in the US (IQVIA MAT December 2018).
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the 8th largest generics pharmaceutical company in terms of market capitalization (28th December 2018, Bloomberg) and the 8th largest generics pharmaceutical company in terms of revenues (30th September 2018, Bloomberg LTM) globally. The Company is the 3rd largest pharmaceutical player in the US by prescriptions for the Total Market (IQVIA MAT December 2018); 3rd largest Indian pharmaceutical company by global revenues (30th September 2018, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan (IQVIA MAT December 2018) and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT December 2018).
For the financial year ended 31st March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinglobal
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries please contact –
VP – Corporate Communications
Ph: +91-22-66402531 / 8291013225
Head – Investor Relations
*Safe Harbor Statement
Prozac® is a registered trademark of Eli Lilly and Company.