Pomalidomide

ANDA 210236, held by Hetero Labs Ltd V. Pomalidomide.

As of Nov 13, 2026, ANDA 210236 (Pomalidomide), held by Hetero Labs Ltd V, was first approved by FDA on Sep 26, 2024, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 26, 2024
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients:

in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. 1.1 Multiple Myeloma Pomalidomide capsules, in combination with dexamethasone, is indicated for adult patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 26, 2024	Original application	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Pomalidomide1MG · capsule;oral	Pomalidomide	Rx
Pomalidomide2MG · capsule;oral	Pomalidomide	Rx
Pomalidomide3MG · capsule;oral	Pomalidomide	Rx
Pomalidomide4MG · capsule;oral	Pomalidomide	Rx

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 27, 2026	Supplement 5REMS	Approved	None posted
Dec 29, 2025	Supplement 2REMS	Approved	None posted
Sep 26, 2024	Original application	Approved	None posted

Identifiers

Application: ANDA 210236
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd

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