A 505(b)(2) approval refers to one given by relying on studies already performed on a previously approved drug.
The product is an alternate salt product of Kowa Company Ltd’s Livalo (Pitavastatin Calcium) Tablets.
It will target patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol, lowdensity lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase high-density lipoprotein cholesterol.
Livalo tablets had US sales of USD 272 million.
Lupin is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, Gl, Anti-infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the sixth largest generics pharmaceutical company by revenue and the fourth largest pharmaceutical player in the US by prescriptions.
For the financial year ended 31 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.