Mumbai: Pharma Major Lupin Limited (Lupin) announced that it has received a 505 (b) (2) NDA approval for its NikitaTM (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (FDA).
Lupin’s NikitaTM (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg are Pitavastatin Sodium, an alternate salt product of Kowa Company Ltd’s Livalo® (Pitavastatin Calcium) Tablets. It is a new option for patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase high-density lipoprotein cholesterol.
Livalo® Tablets had US sales of USD 272 million (IMS MAT June 2017).
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 7th and 6th largest generics pharmaceutical company by market capitalization (June 30th, 2017, Bloomberg) and revenues (March 31st, 2017, Bloomberg) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (Quintiles IMS MAT March 2017); 2nd largest Indian pharmaceutical company by global revenues (March 31st, 2017, Bloomberg); 6th largest generic pharmaceutical player in Japan and 6th largest company in Indian Pharmaceutical Market (Quintiles IMS MAT June 2017).
For the financial year ended 31st March, 2017, Lupin’s Consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited
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 / 9811665000
Head – Investor Relations and M&A
Livalo® is a registered trademark of Kowa Company Ltd