ANDA 209956, held by Teva Pharms USA. Pomalidomide.
As of Nov 13, 2026, ANDA 209956 (Pomalidomide), held by Teva Pharms USA, was first approved by FDA on May 4, 2022, with 3 approved supplements and 0 published complete response letters.
Pomalidomide 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2022 | Original application | Approved |
| 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 9REMS | Approved | None posted |
| Mar 12, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 5, 2025 | Supplement 1REMS | Approved | None posted |
| May 4, 2022 | Original application | Approved |
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
