TheraRadar
Data updated: May 26, 2026

NIKITA (pitavastatin sodium)

Cardiovascular Approved 2017-08-04
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2017-08-04
Routes
ORAL
Dosage Forms
TABLET

Companies

Lupin
Active Ingredient: PITAVASTATIN SODIUM

NIKITA Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2017 to 2023
Oct 2023 SUPPL
Label · Labeling
FDA Letter Label
Sep 2020 SUPPL
Label · Labeling
FDA Letter Label
May 2020 SUPPL
Label · Labeling
FDA Letter Label

What NIKITA Treats

1 FDA approvals

Originally approved for its first indication in 2017 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NIKITA FDA Label Details

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Data Sources

FDA Approval: NDA209875 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.