Treats multiple myeloma. NDA 217110, held by Apotex. Melphalan Hydrochloride.
As of Nov 13, 2026, NDA 217110 (Ivra), held by Apotex, was first approved by FDA on Aug 18, 2023, with 1 approved supplement and 0 published complete response letters.
Multiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. IVRA is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 18, 2023 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| IvraEQ 90MG BASE/ML (EQ 90MG BASE/ML) · solution;intravenous | Melphalan Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Aug 18, 2023 | Original applicationNew dosage form · 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
