Lenalidomide

ANDA 217265, held by Qilu. Lenalidomide.

As of Nov 13, 2026, ANDA 217265 (Lenalidomide), held by Qilu, was first approved by FDA on Feb 22, 2024, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 22, 2024
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lenalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients with:

Multiple myeloma (MM), in combination with dexamethasone.
MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. Limitations of Use:
Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials. 1.1 Multiple Myeloma

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Feb 22, 2024	Original application	Approved	None posted

Products

6 strengths and forms

Product	Active ingredient	Marketing
Lenalidomide2.5MG · capsule;oral	Lenalidomide	Rx
Lenalidomide5MG · capsule;oral	Lenalidomide	Rx
Lenalidomide10MG · capsule;oral	Lenalidomide	Rx
Lenalidomide15MG · capsule;oral	Lenalidomide	Rx
Lenalidomide20MG · capsule;oral	Lenalidomide	Rx
Lenalidomide25MG · capsule;oral	Lenalidomide	Rx

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 27, 2026	Supplement 1REMS	Approved	None posted
Feb 22, 2024	Original application	Approved	None posted

Identifiers

Application: ANDA 217265
Drugs@FDA: Overview at FDA
Company: Qilu

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