Prescription medicine

Melphalan Brand names: Hepzato, Evomela, Ivra; first approved as Alkeran

Melphalan (Hepzato) is a prescription medicine with an FDA approval on record since 1964. FDA's NDC Directory lists it from 13 generic labelers.

Generic listed
A presentation discontinued
Boxed warning

Check it at the source: the melphalan FDA label on DailyMed (effective July 7, 2026, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the NDA 14691 record on Drugs@FDA; every melphalan label on DailyMed.

Highlights of the record

FDA label of July 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

Melphalan should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) to oral melphalan have shown more myelosuppression with the IV formulation. Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation. Melphalan is leukemogenic in humans. Melphalan produces chromosomal aberrations in vitro and in vivo and, therefore, should be considered potentially mutagenic in humans.

Used for

From the label: indications and usage
Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Forms and strengths

50 mg/10ml
90 mg/ml

Kit; injection (powder) (lyophilized) for solution; injection (solution).

On the market

Earliest approval on file: January 17, 1964 Alkeran, Apotex; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 19 first June 9, 2009; 12 with a marketed status in Drugs@FDA
Labelers listed (NDC): 16 of which 13 under generic applications, 3 under brand applications, repackagers included
Last listed patent: September 17, 2034 Hepzato powder; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): None current 1 past records
Recalls by its makers (FDA): No recall recorded
FAERS reports: 24,926 through July 30, 2026

What is melphalan used for?

From the label: indications and usage
Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Conditions named in the indications of melphalan's FDA labels, with every medicine labeled for each:

Leukemia, lymphoma and myeloma

From other melphalan labels
Leukemia, lymphoma and myeloma: INDICATIONS AND USAGE Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

FDA pharmacologic class: Alkylating Drug.

Source: FDA drug label (Melphalan hydrochloride), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective July 7, 2026 (SPL set 2c18beeb-7bd4-4591-94cb-9d7156c1b8e0), via openFDA; the full label on DailyMed

Is there a generic for melphalan (Hepzato)?

The FDA approved the first generic melphalan on June 9, 2009. 19 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists melphalan from 13 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 10 patents for Hepzato powder, the last expiring on September 17, 2034; a patent listed only for Ivra injection runs to June 29, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

1964 earliest approval on file
2009 first generic approved
2034 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Is melphalan in shortage?

No melphalan presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated September 16, 2026. ASHP keeps a separate shortage list, which can differ.

Presentation	Company	Status	Updated
Melphalan Hydrochloride, Injection, Kit (NDC 63323-760-20)	Fresenius Kabi USA, LLC	To Be Discontinued	September 16, 2026

Every melphalan presentation in the FDA shortage database

Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026

What does the melphalan label say about other medicines?

The melphalan label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name melphalan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Aspirin	warnings and precautions	Discontinue drugs affecting platelet function such as aspirin, non-steroidal anti-inflammatory drugs, or other anti-platelet drugs one week before the procedure.
Cisplatin	drug interactions	Cisplatin may affect melphalan kinetics by inducing renal dysfunction and subsequently altering melphalan clearance.
Cyclosporine	drug interactions	Drug Interactions The development of severe renal failure has been reported in patients treated with a single dose of IV melphalan followed by standard oral doses of cyclosporine.
Heparin	contraindications	… HEPZATO KIT including History of allergy to natural rubber latex History of allergy or hypersensitivity to heparin or presence of heparin-induced thrombocytopenia (HIT) History of severe allergic reaction to iodinated contrast not controlled by premedication with antihistamines and steroids Active intracranial …
Warfarin	warnings and precautions	Discontinue anticoagulation with warfarin or other oral anticoagulants prior to the procedure; resume when hemostasis has been restored after the procedure, provided no bleeding complications have been observed.

Other labels that name melphalan

Check melphalan against other medicines

What do FAERS reports show for melphalan?

The FDA Adverse Event Reporting System holds 24,926 reports that list melphalan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,941 are coded as a death and 7,187 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Off Label Use (a use or a product term, not a reaction)2,494
Drug Ineffective (a use or a product term, not a reaction)1,473
Febrile Neutropenia1,316
Plasma Cell Myeloma1,274
Neutropenia1,234
Mucosal Inflammation1,229
Pyrexia (named in the label)1,174
Pneumonia1,152

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as melphalan?

36 other medicines are given the same way (intravenous) and in the same FDA class as melphalan or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (intravenous)	Pharmacy cost	Shortage
Cyclophosphamide	Leukemia, lymphoma and myeloma	15 labelers	n/a	No current entry
Bendamustine	Leukemia, lymphoma and myeloma	4 labelers	n/a	A presentation being discontinued
Carmustine	Leukemia, lymphoma and myeloma	3 labelers	n/a	No current entry
Doxorubicin	Leukemia, lymphoma and myeloma	16 labelers	n/a	No current entry
Bortezomib	Leukemia, lymphoma and myeloma	22 labelers	n/a	No current entry
Arsenic trioxide	Leukemia, lymphoma and myeloma	16 labelers	n/a	A presentation being discontinued
Nelarabine	Leukemia, lymphoma and myeloma	12 labelers	n/a	No current entry
Idarubicin	Leukemia, lymphoma and myeloma	2 labelers	n/a	No current entry

Every medicine labeled for the same conditions as melphalan

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to melphalan: 36 medicines for the same use
Other alkylating drugs: the pharmacologic class, with prices and generics
Melphalan side effects: the label's list beside FAERS reports
Melphalan shortage record: every presentation, company and date
Check an interaction: what two or more labels say about each other