Nikita Approved for Cholesterol
August 4, 2017 – The U.S. FDA has approved Nikita™ (pitavastatin sodium) tablets, manufactured by Lupin. Nikita is indicated to regulate cholesterol, lipoprotein, and triglyceride levels for patients who have primary hyperlipidemia or mixed dyslipidemia, and should be used in combination with diet changes and exercise. With a recommended dosing of once per day, Nikita tablets will be available in 1mg, 2mg, and 4mg dosage strengths.
Approval for Nikita was obtained through the FDA’s 505(b)(2) pathway, which allowed Lupin to use Livalo® (pitavastatin calcium), manufactured by Kowa Company, as a reference product. Nikita is an alternate salt product, meaning that it is not considered a generic of Livalo, and is not automatically interchangeable. No pricing or launch plans have been announced.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.