Regulatory PathRegulatory requirements compared

Active substance

Anagrelide

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
AGRYLINEQ 0.5MG BASEcapsule · oralTAKEDA PHARMS USAPrescription14 Mar 1997
ANAGRELIDE HYDROCHLORIDEEQ 0.5MG BASE; EQ 1MG BASEcapsule · oralCIPLAPrescription18 Apr 2005
ANAGRELIDE HYDROCHLORIDEEQ 0.5MG BASE; EQ 1MG BASEcapsule · oralNOVITIUM PHARMAPrescription18 Apr 2005
ANAGRELIDE HYDROCHLORIDEEQ 0.5MG BASE; EQ 1MG BASEcapsule · oralIMPAX LABSPrescription18 Apr 2005
ANAGRELIDE HYDROCHLORIDEEQ 0.5MG BASE; EQ 1MG BASEcapsule · oralTORRENTPrescription30 Jun 2017
AGRYLINEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralTAKEDA PHARMS USADiscontinued14 Mar 1997
ANAGRELIDE HYDROCHLORIDEEQ 0.5MG BASE; EQ 1MG BASEcapsule · oralWATSON LABSDiscontinued18 Apr 2005
ANAGRELIDE HYDROCHLORIDEEQ 0.5MG BASE; EQ 1MG BASEcapsule · oralROXANEDiscontinued18 Apr 2005
ANAGRELIDE HYDROCHLORIDEEQ 0.5MG BASE; EQ 1MG BASEcapsule · oralBARR LABSDiscontinued18 Apr 2005
ANAGRELIDE HYDROCHLORIDEEQ 0.5MG BASE; EQ 1MG BASEcapsule · oralCHARTWELL RXDiscontinued18 Apr 2005
ANAGRELIDE HYDROCHLORIDEEQ 0.5MG BASE; EQ 1MG BASEcapsule · oralRISINGDiscontinued27 Jun 2006

EMA European Union — centrally authorised medicines

Xagrid Takeda Pharmaceuticals International AG Ireland · Authorised · authorised 15 Nov 2004 · ATC L01XX35

Therapeutic indication (EMA)

Xagrid is indicated for the reduction of elevated platelet counts in at-risk essential-thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy. An at-risk patient An at-risk ET is defined by one or more of the following features: >60 years of age or; a platelet count >1000 x 109/l or; a history of thrombohaemorrhagic events.

Anagrelide Viatris (previously Anagrelide Mylan) Viatris Limited · Authorised · authorised 15 Feb 2018 · ATC L01XX35

Therapeutic indication (EMA)

Anagrelide Viatris is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.An at-risk patient An at-risk essential thrombocythaemia patient is defined by one or more of the following features: >60 years of age or a platelet count >1,000 x 10⁹/l or a history of thrombo-haemorrhagic events.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PMS-ANAGRELIDE022749490.5 MGCAPSULE · ORALPHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACANAGRELIDE HCL 0.5 MG CAPSULE$0.72949per EA23 Sep 2026
US NADACANAGRELIDE HCL 1 MG CAPSULE$1.41317per EA23 Sep 2026
NHS Drug TariffAnagrelide 500microgram capsules£249.99100 capsule1 Oct 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 13 Oct 2021 AGRYLIN — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for anagrelide →

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.