Zydelig

Treats relapsed chronic lymphocytic leukemia (CLL). NDA 205858, held by Gilead Sciences Inc. Idelalisib.

As of Nov 15, 2026, NDA 205858 (Zydelig), held by Gilead Sciences Inc, was first approved by FDA on Jul 23, 2014, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 23, 2014
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is a kinase inhibitor indicated for the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jul 23, 2014	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Zydelig100MG · tablet;oral	Idelalisib	RxReference drug
Zydelig150MG · tablet;oral	Idelalisib	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Jul 6, 2022	Supplement 18REMS	Approved	Letter
Mar 10, 2022	Supplement 17REMS	Approved	Letter
Feb 18, 2022	Supplement 16Labeling · Standard review	Approved	Label Medication Guide Letter
Oct 19, 2020	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 10, 2018	Supplement 13Labeling · Standard review	Approved	Letter Label
Mar 22, 2018	Supplement 12REMS	Approved	Letter
Feb 6, 2018	Supplement 10REMS	Approved	Letter
Feb 2, 2018	Supplement 11Labeling · Standard review	Approved	Letter Label
Jan 26, 2018	Supplement 9Labeling · Standard review	Approved	Label Letter
Nov 29, 2017	Supplement 7Labeling · Standard review	Approved	Letter Label
Jan 4, 2017	Supplement 5REMS	Approved	Letter
Sep 21, 2016	Supplement 4Labeling · Standard review	Approved	Label Letter
Jan 19, 2016	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 1, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 23, 2014	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 205858
Drugs@FDA: Overview at FDA
Company: Gilead Sciences

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters