Is Vorapaxar approved by the US FDA?

Drugs@FDA lists 1 application product line for Vorapaxar, including ZONTIVITY (Discontinued).

Is Vorapaxar authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Vorapaxar.

Are there safety signals or safety updates for Vorapaxar?

US FDA: 1 entry (latest 2019-11-07).

Active substance

Vorapaxar

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZONTIVITY	EQ 2.08MG BASE	tablet · oral	KEY THERAP	Discontinued	8 May 2014

EMA European Union — centrally authorised medicines

Zontivity Merck Sharp Dohme Limited · Withdrawn · authorised 19 Jan 2015 · ATC B01

Therapeutic indication (EMA)

Zontivityis indicated for the reduction of atherothrombotic events in adult patients with a history of myocardial infarction (MI), ,co-administered with acetylsalicylic acid (ASA) and, where appropriate, clopidogrel; or symptomatic peripheral arterial disease (PAD), co-administered with acetylsalicylic acid (ASA) or, where appropriate, clopidogrel.

Safety signals and safety-related labeling changes

US FDA 7 Nov 2019 ZONTIVITY — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for vorapaxar →

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.