ANDA 213234, held by Dr Reddys. Pomalidomide.
As of Nov 13, 2026, ANDA 213234 (Pomalidomide), held by Dr Reddys, was first approved by FDA on Aug 31, 2026, with 0 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 |
|---|---|---|---|
| Aug 31, 2026 | 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 |
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
