ANDA 217281, held by Novugen. Lenalidomide.
As of Nov 13, 2026, ANDA 217281 (Lenalidomide), held by Novugen, was first approved by FDA on Sep 11, 2024, with 1 approved supplement and 0 published complete response letters.
Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone. MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Previously treated follicular lymphoma (FL), in combination with a rituximab product.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 11, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lenalidomide2.5MG · capsule;oral | Lenalidomide | Rx |
| Lenalidomide5MG · capsule;oral | Lenalidomide | Rx |
| Lenalidomide10MG · capsule;oral | Lenalidomide | Rx |
| Lenalidomide15MG · capsule;oral | Lenalidomide | Rx |
| Lenalidomide20MG · capsule;oral | Lenalidomide | Rx |
| Lenalidomide25MG · capsule;oral | Lenalidomide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2026 | Supplement 3REMS | Approved | None posted |
| Sep 11, 2024 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
