Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 2
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.
Authors and Affiliations
Sara Gaspani, Barbara Milani
Keywords
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- EP ID EP354936
- DOI 10.5639/gabij.2013.0202.022
- Views 118
- Downloads 0
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