Pomalidomide

ANDA 220741, held by Sandoz. Pomalidomide.

As of Nov 13, 2026, ANDA 220741 (Pomalidomide), held by Sandoz, was first approved by FDA on Aug 31, 2026, with 0 approved supplements and 0 published complete response letters.

First approved: Aug 31, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pomalidomide capsules are 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

Date	Submission	Status	Documents
Aug 31, 2026	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

Identifiers

Application: ANDA 220741
Drugs@FDA: Overview at FDA
Company: Sandoz

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