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Lupin receives tentative U.S. FDA approval for Mirabegron ER Tablets
Mumbai, Baltimore, June 27, 2019: Pharma major Lupin Limited (Lupin) announced that it has received tentative approval for its Mirabegron Extended Release (ER) Tablets, 25 mg and 50 mg, from the United States Food and Drug Administration (FDA), to market a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development Inc. (Astellas).
Lupin’s Mirabegron ER Tablets, 25 mg and 50 mg, is a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of Astellas. It is indicated for the treatment of Overactive Bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Mirabegron ER Tablets 25 mg and 50 mg (RLD: Myrbetriq) had annual sales of approximately USD 1501.6 mn in the US (IMS MAT March 2019).
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biosimilar 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 by revenues (31st Dec 2018, Bloomberg LTM). The Company is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA MAT Mar 2019); 3rd largest Indian pharmaceutical company by global revenues (31st Dec 2018, Bloomberg LTM); 5th largest company in the Indian Pharmaceutical Market and 6th largest generic pharmaceutical player in Japan (IQVIA MAT Mar 2019).
For the financial year ended 31st March 2019, Lupin’s Consolidated sales and Net profits before exceptional items were at INR 163,694 million (USD 2.34 billion) and INR 9,466 million (USD 136 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter at – 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 6640 2531 / 9811665000
Head – Investor Relations
Ph: +91-22 6640 8237
*Safe Harbor Statement
Myrbetriq ® is a registered trademark of Astellas Pharma Inc.