FDA — authorised 30 October 2020
- Application: ANDA210249
- Marketing authorisation holder: EUGIA PHARMA
- Status: supplemented
🇺🇸 POMALIDOMIDE in United States
FDA authorised POMALIDOMIDE on 30 October 2020 · 9,933 US adverse-event reports
Marketing authorisations
FDA — authorised 30 October 2020
- Application: ANDA210111
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: POMALIDOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 January 2022
- Application: ANDA210275
- Marketing authorisation holder: MYLAN
- Local brand name: POMALIDOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 May 2022
- Application: ANDA209956
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: POMALIDOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 June 2024
- Application: ANDA210164
- Marketing authorisation holder: APOTEX
- Local brand name: POMALIDOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 September 2024
- Application: ANDA210236
- Marketing authorisation holder: HETERO LABS LTD V
- Status: supplemented
FDA
- Application: ANDA213234
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: POMALIDOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 9,933
Most-reported reactions
- Plasma Cell Myeloma — 2,255 reports (22.7%)
- Neutropenia — 1,478 reports (14.88%)
- Pneumonia — 1,080 reports (10.87%)
- Off Label Use — 970 reports (9.77%)
- Death — 857 reports (8.63%)
- Thrombocytopenia — 827 reports (8.33%)
- Anaemia — 775 reports (7.8%)
- Drug Ineffective — 589 reports (5.93%)
- Fatigue — 564 reports (5.68%)
- Pyrexia — 538 reports (5.42%)
POMALIDOMIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is POMALIDOMIDE approved in United States?
Yes. FDA authorised it on 30 October 2020; FDA authorised it on 30 October 2020; FDA authorised it on 26 January 2022.
Who is the marketing authorisation holder for POMALIDOMIDE in United States?
EUGIA PHARMA holds the US marketing authorisation.