Lupin receives FDA approval for generic Atovaquone Oral Solution USP
Mumbai, September 12, 2018: Pharma major Lupin announced that it has received approval for its Atovaquone Oral Suspension USP, 750 mg/5 mL from the United States Food and Drug Administration (FDA) to market a generic version of GlaxoSmithKline LLC’s Mepron Oral Suspension, 750 mg/5 mL.
Lupin’s Atovaquone Oral Suspension USP, 750 mg/5 mL is the generic version of GlaxoSmithKline LLC’s Mepron Oral Suspension, 750 mg/5 mL. It is indicated for prevention and acute oral treatment of mild-to-moderate Pneumocystis carinii pneumonia (PCP) in patients intolerant to trimethoprim-sulfamethoxazole (TMP-SMX).
Atovaquone Oral Suspension, 750 mg/5 mL had annual sales of approximately USD 117.4 million in the US (IQVIA MAT June 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 both in terms of market capitalization (30th June 2018, Bloomberg) and revenues (31st March 2018, Bloomberg LTM) globally. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT June 2018); 3rd largest Indian pharmaceutical company by global revenues (31st March 2018, Bloomberg LTM); 6 th largest generic pharmaceutical player in Japan and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT June 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 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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Mepron is a registered trademark of GlaxoSmithKline LLC