For multiple myeloma. NDA 207155, held by Acrotech Biopharma. Melphalan Hydrochloride.
As of Nov 13, 2026, NDA 207155 (Evomela), held by Acrotech Biopharma, was first approved by FDA on Mar 10, 2016, with 3 approved supplements and 0 published complete response letters.
Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. 1.1 Multiple Myeloma-Conditioning Treatment
| Mar 10, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved | |
| Mar 10, 2016 | Original applicationEfficacy (new indication or use) · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| EvomelaEQ 50MG BASE/VIAL · powder;intravenous | Melphalan Hydrochloride | RxReference drug |
| Apr 26, 2022 | Supplement 5Labeling · Standard review | Approved | |
| Aug 9, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Sep 25, 2017 | Supplement 1Manufacturing | Approved | |
| Mar 10, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved | |
| Mar 10, 2016 | Original applicationEfficacy (new indication or use) · Standard review | Approved |
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
