FDA approves Lupin’s Nikita

SILVER SPRING, Md. — The Food and Drug Administration has granted Lupin approval for its Nikita (pitavastatin sodium) tablets, the company announced Wednesday. The drug is indicated as an adjunctive therapy to diet to reduce high total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides while raising HDL cholesterol.

 

Lupin said it is an alternate salt product of Kowa’s Livalo (pitavastatin calcium). There is no generic of Livalo that has been approved by the FDA. 

 

Nikita will be available in 1-, 2- and 4-mg dosage strengths. The drug had U.S. sales of $272 million for the 12 months ended June 2017, according to QuintilesIMS data.