Eagle Pharmaceuticals, Inc.
FORMULATIONS OF BENDAMUSTINE
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Abstract:
Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response ("PAR") basis as determined by high performance liquid chromatography ("HPLC") at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5.degree. C. to about 25.degree. C.
Status:
Application
Type:
Utility
Filling date:
26 Aug 2021
Issue date:
23 Dec 2021