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Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx | Journal Article / Letter | MSF Science Portal
Journal Article
|Letter

Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx

Gaspani S, Milani B

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Abstract
The lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB), the WHO-recommended drug for visceral leishmaniasis. The approval of the first generic liposomal product by the US Food and Drug Administration in February 2013 could be a turning point, and serve as a basis for WHO to develop guidance for the evaluation of generic liposomal formulations.

Countries

none

Subject Area

neglected tropical diseaseskala azaraccess to health care

Languages

English
DOI
10.5639/gabij.2013.0202.022
Published Date
13 May 2013
Journal
Generics and Biosimilars Initiative Journal
Volume | Issue | Pages
Volume 2, Issue 2
Issue Date
2013-06-15
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