ANDA 219718, held by Cipla. Pomalidomide.
As of Nov 13, 2026, ANDA 219718 (Pomalidomide), held by Cipla, was first approved by FDA on Aug 31, 2026, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE 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 | 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
