Pomalyst

NDA 204026, held by Bristol. Pomalidomide.

As of Nov 13, 2026, NDA 204026 (Pomalyst), held by Bristol, was first approved by FDA on Feb 8, 2013, with 26 approved supplements and 0 published complete response letters.

First approved: Feb 8, 2013
Review: Priority
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

POMALYST 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.
with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Nov 20, 2020	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 14, 2020	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 14, 2020	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Label Letter
Apr 23, 2015	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 8, 2013	Original applicationNew molecular entity · Priority review	Approved	Summary Review Review Other Letter

Products

4 strengths and forms


Pomalyst1MG · capsule;oral	Pomalidomide	RxReference drug
Pomalyst2MG · capsule;oral	Pomalidomide	RxReference drug
Pomalyst3MG · capsule;oral	Pomalidomide	RxReference drug
Pomalyst4MG · capsule;oral	Pomalidomide	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


Apr 27, 2026	Supplement 35REMS	Approved	Letter
Feb 26, 2025	Supplement 34REMS	Approved	Letter Label Medication Guide
Mar 24, 2023	Supplement 31REMS	Approved	Letter Label
Aug 5, 2021	Supplement 29REMS	Approved	Letter
Dec 3, 2020	Supplement 28Labeling · Standard review	Approved	Letter Label
Nov 20, 2020	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 14, 2020	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 14, 2020	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 30, 2019	Supplement 21Labeling · Standard review	Approved	Letter Label
Mar 20, 2018	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 29, 2017	Supplement 19Labeling · Standard review	Approved	Label Letter
Nov 30, 2017	Supplement 18Labeling · Standard review	Approved	Label Letter
Jun 27, 2017	Supplement 16REMS	Approved	Letter
Jun 30, 2016	Supplement 14Labeling · Standard review	Approved	Label Letter
Jun 30, 2016	Supplement 12Labeling · Standard review	Approved	Label Letter
Apr 22, 2016	Supplement 13REMS	Approved	Letter
Dec 1, 2015	Supplement 11REMS	Approved	Letter
Oct 27, 2015	Supplement 10REMS	Approved	Letter
Sep 14, 2015	Supplement 9REMS	Approved	Letter
Apr 23, 2015	Supplement 8Labeling · Standard review	Approved	Label Letter
Apr 23, 2015	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 23, 2015	Supplement 5Labeling	Approved	Label Letter
Sep 12, 2014	Supplement 4REMS	Approved	Letter
Mar 13, 2014	Supplement 3Labeling · Standard review	Approved	Letter Label
Nov 15, 2013	Supplement 2REMS	Approved	Letter
Oct 3, 2013	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 8, 2013	Original applicationNew molecular entity · Priority review	Approved	Summary Review Review Other Letter

Identifiers

Application: NDA 204026
Drugs@FDA: Overview at FDA
Company: Bristol Laboratories

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