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Evomela Approval History

Evomela (melphalan) is an alkylating agent used as a high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma (MM), and for the palliative treatment of patients with MM for whom oral therapy is not appropriate.

FDA approval of Evomela was based on its bioequivalence to the standard melphalan formulation (Alkeran) in a Phase 2 clinical study. It marks the first new formulation of melphalan developed since its initial approval in 1964.

Conventional formulations of melphalan (such as Alkeran) have marginal solubility, limited chemical stability and require propylene glycol as a co-solvent, which is associated with renal dysfunction and arrhythmias. Evomela is a propylene glycol-free formulation of melphalan that incorporates Captisol® technology to improve solubility, stability, and bioavailability. Evomela is stable for four hours at room temperature, and after reconstitution with normal saline, is stable for one hour at room temperature and 24 hours at refrigerated temperature (5°C).

Development History and FDA Approval Process for Evomela

DateArticle
Mar 15, 2016Approval FDA Grants Spectrum Pharmaceuticals Approval of Evomela (melphalan) for Injection

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