Is Idelalisib approved by the US FDA?

Drugs@FDA lists 3 application product lines for Idelalisib, including ZYDELIG (Prescription); ZYDELIG (Prescription); IDELALISIB (Discontinued).

Is Idelalisib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Idelalisib: Zydelig.

Are there safety signals or safety updates for Idelalisib?

EMA PRAC: 4 entries; US FDA: 1 entry; MHRA: 2 entries (latest 2022-02-18).

Active substance

Idelalisib

US FDA 3
EMA 1
Health Canada 2
Safety 7

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ZYDELIG	100MG; 150MG	tablet · oral	GILEAD SCIENCES INC	Prescription	23 Jul 2014
ZYDELIG	100MG; 150MG	tablet · oral	GILEAD SCIENCES INC	Prescription	23 Jul 2014
IDELALISIB	100MG; 150MG	tablet · oral	NATCO	Discontinued	17 Feb 2026

EMA European Union — centrally authorised medicines

Zydelig Gilead Sciences Ireland UC · Authorised · authorised 18 Sep 2014 · ATC L01XX47

Therapeutic indication (EMA)

Zydelig is indicated in combination with an anti?CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ZYDELIG	02438798	100 MG	TABLET · ORAL	GILEAD SCIENCES CANADA INC
ZYDELIG	02438801	150 MG	TABLET · ORAL	GILEAD SCIENCES CANADA INC

Safety signals and safety-related labeling changes

US FDA 18 Feb 2022 ZYDELIG — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 17 Apr 2020 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: Yes
EMA PRAC 28 Nov 2019 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
EMA PRAC 11 Apr 2019 PRAC signal: Arthritis and arthralgia
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Arthritis and arthralgia
Action for MAH: update of the product information: No
MHRA 15 Sep 2016 Idelalisib (Zydelig▼): updated indications and advice on minimising the risk of infection
Updated advice for healthcare professionals is available, after conclusion of a review of the safety of idelalisib, including the risk of infection.
MHRA 10 May 2016 Idelalisib (Zydelig▼): interim measures following signal of serious infection and deaths related to infection found in clinical trials
There are new interim treatment recommendations for idelalisib for chronic lymphocytic leukaemia and follicular lymphoma in light of new findings from clinical trials outside its currently authorised drug combinations or indicated populations.

All safety entries for idelalisib →

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.