SILVER SPRING, Md. — The Food and Drug Administration has granted Lupin approval for its Nikita, a generic of Livalo (pitavastatin) 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.
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.