At this time, Alkeran (melphalan) tablets are available in brand-name form only. However, the injectable form of Alkeran is available as a generic. The generic Alkeran injections have been shown to be equivalent to the brand-name version, although the generics may contain different inactive ingredients. It is unknown when a generic version of the tablets will become available.
Can I Buy Generic Alkeran?
Alkeran® (melphalan) is a prescription anticancer medicine that comes as an oral medication (a tablet taken by mouth) and an injectable medication that is given into a vein (intravenous, or IV, infusion). It is approved to treat multiple myeloma (a cancer of the plasma cells, a type of white blood cell) and ovarian cancer (cancer of the ovaries).
Alkeran injection is manufactured by GlaxoSmithKline. Alkeran tablets are manufactured by Excella GmbH for GlaxoSmithKline. Both forms of Alkeran are distributed by ApoPharma USA. Alkeran tablets are not available in generic form, but the injection is available as a generic.
Generic melphalan is available in one strength and form: Melphalan 50 mg for injection.
Who Makes Generic Alkeran?
Generic Alkeran is made by a couple of different companies, including Bioniche Pharma USA and Novaplus.
Is Generic Melphalan as Good as Alkeran?
All generic medications must undergo certain tests to compare them to brand-name medications. The U.S. Food and Drug Administration (FDA) then looks at these tests to decide if the generics are equivalent to the brand-name medications and assigns each generic a rating.
An "AP" rating means that the FDA has determined that a generic injectable medication is equivalent to a brand-name medication. All of the generic Alkeran versions currently available have an "AP" rating, meaning they should be equivalent to Alkeran.
However, generic medications are allowed to have different inactive ingredients than the brand-name medication. This might include fillers, dyes, or other ingredients that may cause problems for people with allergies or sensitivities.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Alkeran [package insert]. Rockville, MD: ApoPharma USA, Inc.;November 2011.
Alkeran Tablet [package insert]. Rockville, MD: ApoPharma USA, Inc.;June 2011.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed September 3, 2012.
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