ANDA 216213, held by Amneal. Lenalidomide.
As of Nov 13, 2026, ANDA 216213 (Lenalidomide), held by Amneal, was first approved by FDA on Jan 31, 2025, 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. Limitations of Use: Lenalidomide capsules is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials. 1.1 Multiple Myeloma
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 2025 | 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 1REMS | Approved | None posted |
| Jan 31, 2025 | 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
