Active substance
Pitavastatin
- SFDA 4
- US FDA 12
- US price lines 6
- Safety 8
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| VALIP 2 mg film-coated tablets | 2 mg | Film-coated tablet · Oral use | 30 Blister | SAR 54.85 | Generic · Prescription | Abbott Laboratories GmbH | Valid |
| VALIP 4 mg film-coated tablets | 4 mg | Film-coated tablet · Oral use | 30 Blister | SAR 64.50 | Generic · Prescription | Abbott Laboratories GmbH | Valid |
| LIVAZO 2 mg film-coated tablets | 2 mg | Film-coated tablet · Oral use | 28 Blister | SAR 67.50 | NCE · Prescription | Algorithm SAL | Suspended |
| LIVAZO 4 mg film-coated tablets | 4 mg | Film-coated tablet · Oral use | 28 Blister | SAR 79.40 | NCE · Prescription | Algorithm SAL | Suspended |
Indications — CHI Daman Drug Formulary
ANTIPHOSPHOLIPID SYNDROME; CORONARY ARTERY DISEASE; DYSLIPIDEMIA; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI)
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LIVALO | EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE | tablet · oral | KOWA CO | Prescription | 3 Aug 2009 |
| PITAVASTATIN CALCIUM | EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE | tablet · oral | AUROBINDO PHARMA | Prescription | 20 Dec 2016 |
| PITAVASTATIN CALCIUM | EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE | tablet · oral | ORIENT PHARMA CO LTD | Prescription | 3 Feb 2017 |
| PITAVASTATIN CALCIUM | EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE | tablet · oral | SAWAI USA | Prescription | 3 Feb 2017 |
| ZYPITAMAG | EQ 2MG BASE; EQ 4MG BASE | tablet · oral | MEDICURE | Prescription | 14 Jul 2017 |
| PITAVASTATIN CALCIUM | EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE | tablet · oral | MYLAN | Prescription | 4 Apr 2019 |
| PITAVASTATIN CALCIUM | EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE | tablet · oral | ZYDUS PHARMS | Prescription | 22 Feb 2023 |
| PITAVASTATIN CALCIUM | EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE | tablet · oral | LUPIN | Prescription | 20 Nov 2023 |
| PITAVASTATIN CALCIUM | EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE | tablet · oral | HETERO LABS LTD V | Prescription | 30 Apr 2024 |
| PITAVASTATIN CALCIUM | EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE | tablet · oral | AMNEAL PHARMS NY | Prescription | 20 Aug 2024 |
| ZYPITAMAG | EQ 1MG BASE | tablet · oral | MEDICURE | Discontinued | 14 Jul 2017 |
| NIKITA | EQ 1MG BASE; EQ 2MG BASE; EQ 4MG BASE | tablet · oral | LUPIN | Discontinued | 4 Aug 2017 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | LIVALO 1 MG TABLET | $10.21149 | per EA | 23 Sep 2026 |
| US NADAC | LIVALO 2 MG TABLET | $10.20605 | per EA | 23 Sep 2026 |
| US NADAC | LIVALO 4 MG TABLET | $10.22248 | per EA | 23 Sep 2026 |
| US NADAC | PITAVASTATIN 1 MG TABLET | $0.90443 | per EA | 23 Sep 2026 |
| US NADAC | PITAVASTATIN 2 MG TABLET | $0.95425 | per EA | 23 Sep 2026 |
| US NADAC | PITAVASTATIN 4 MG TABLET | $1.02909 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 14 Mar 2024 LIVALO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 31 Jan 2024 ZYPITAMAG — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 30 Oct 2023 NIKITA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 13 Jan 2023 PRAC signal: Myasthenia gravis
Action for MAH: update of the product information: Yes - EMA PRAC 7 Jul 2022 PRAC signal: Myasthenia gravis
Action for MAH: update of the product information: No - EMA PRAC 11 Feb 2021 PRAC signal: Bullous pemphigoid
Action for MAH: update of the product information: No - EMA PRAC 3 Sep 2020 PRAC signal: Bullous pemphigoid
Action for MAH: update of the product information: No - EMA PRAC 11 Jun 2015 PRAC signal: Lichenoid drug eruption
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.