Quick answers
- What is Pomalidomide used for?
- The FDA-approved label (Pomalyst, Celgene Corporation, February 26, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pomalidomide have a boxed warning?
- Yes. The FDA label for Pomalyst has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Pomalidomide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pomalidomide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pomalidomide?
- 12 companies list prescription products of Pomalidomide in the FDA NDC Directory, including Aurobindo Pharma Limited, Natco Pharma Limited and Teva Pharmaceuticals, Inc..
What Pomalidomide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Pomalyst, Celgene Corporation, effective February 26, 2025. Read the full label on DailyMed →
The FDA has 11 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
11 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 47 in the FDA NDC Directory |
| Brand names | Pomalyst |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Aurobindo Pharma Limited4 products
- Natco Pharma Limited4 products
- Teva Pharmaceuticals, Inc.4 products
- Dr. Reddy's Laboratories Inc.4 products
- Apotex Corp.4 products
- Sandoz Inc4 products
- Camber Pharmaceuticals, Inc.4 products
- Cipla USA Inc.4 products
- Sun Pharmaceutical Industries, Inc.4 products
- Celgene Corporation4 products
- Breckenridge Pharmaceutical, Inc.4 products
- Novadoz Pharmaceuticals LLC3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204026 POMALYST | Bristol | February 8, 2013 | 26, latest April 27, 2026 2026: REMS · 2025: REMS · 2023: REMS |
Generic approvals (10)
- ANDA210111Breckenridge · October 30, 2020
- ANDA210249Eugia Pharma · October 30, 2020
- ANDA209956Teva Pharms USA · May 4, 2022
- ANDA210164Apotex · June 11, 2024
- ANDA210236Hetero Labs Ltd V · September 26, 2024
- ANDA210232Spil · August 31, 2026
- ANDA213234DR Reddys · August 31, 2026
- ANDA219718Cipla · August 31, 2026
- ANDA220741Sandoz · August 31, 2026
- ANDA210245Msn · September 2, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pomalyst, Celgene Corporation, effective February 26, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →