Lupin receives US FDA approval for Clobazam Tablets, 10 mg and 20 mg
Mumbai, Baltimore, December 17, 2018: Pharma major Lupin announced that it has received approval for its Clobazam Tablets, 10 mg and 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Lundbeck Pharmaceuticals, LLC's Onfi Tablets, 10 mg and 20 mg.
Lupin's Clobazam Tablets, 10 mg and 20 mg is the generic version of Lundbeck Pharmaceuticals, LLC's Onfi Tablets, 10 mg and 20 mg. It is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Onfi Tablets, 10 mg and 20 mg had annual sales of approximately USD $601.2 million in the US (IQVIA MAT September 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 13th largest generics pharmaceutical company in terms of market capitalization (30th September 2018, Bloomberg) and the 8th largest generics pharmaceutical company in terms of revenues (30th June 2018, Bloomberg LTM) globally. The Company is the 3rd largest pharmaceutical player in the US by prescriptions for the Total Market (IQVIA MAT September 2018); 3rd largest Indian pharmaceutical company by global revenues (30th June 2018, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan (IQVIA MAT September 2018) and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT September 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.
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Onfi® is a registered trademark of Lundbeck LLC.