ANDA 210164, held by Apotex. Pomalidomide.
As of Nov 13, 2026, ANDA 210164 (Pomalidomide), held by Apotex, was first approved by FDA on Jun 11, 2024, with 2 approved supplements and 0 published complete response letters.
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. 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 11, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pomalidomide1MG · capsule;oral | Pomalidomide | Rx |
| Pomalidomide2MG · capsule;oral | Pomalidomide | Rx |
| Pomalidomide3MG · capsule;oral | Pomalidomide | Rx |
| Pomalidomide4MG · capsule;oral | Pomalidomide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2026 | Supplement 7REMS | Approved | None posted |
| Feb 26, 2025 | Supplement 2REMS | Approved | None posted |
| Jun 11, 2024 | Original application | Approved | None posted |
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
