Lupin has received a 505 (b) (2) NDA approval for its Nikita (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (USFDA).
Lupin’s Nikita (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg are Pitavastatin Sodium, an alternate salt product of Kowa Company’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 $272 million, as per IMS MAT June 2017.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.
