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.
No takes yet. Share an insight, caveat, or question.
Sara Gaspani (2013) studied this question.
Synapse has enriched 5 related papers. Consider them for comparative context: