ANDA 210232, held by Spil. Pomalidomide.
As of Nov 13, 2026, ANDA 210232 (Pomalidomide), held by Spil, was first approved by FDA on Aug 31, 2026, with 0 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. 1.1 Multiple Myeloma Pomalidomide capsules, in combination with dexamethasone, is indicated for adult 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2026 | 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 |
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
