FDA Allows Halcygen’s IND Application, Pivotal US-Based Clinical Trials To Proceed - SUBATM-Itraconazole Is An Improved Anti-fungal

HalcyGen Pharmaceuticals Limited (ASX:HGN) has received approval from the US Food and Drug Administration (FDA) to begin pivotal pharmacokinetic* (PK) studies in the United States. These studies are the precursor to SUBATM-Itraconazole product registration. The allowance to proceed comes 30 days after HalcyGen submitted its Investigational New Drug (IND) application (announced 14 May 2008).

More: continued here

Filed under: Clinical Trials on June 19th, 2008