PDUFA run up to November 5 release. "The NDA for Macrilen™ continues to be under review, with a PDUFA date of November 5".
• Continued discussions with the FDA and provided the agency with further information regarding the New Drug Application ("NDA") review for Macrilen™, which seeks approval as the first orally-administered drug for the evaluation of Adult Growth Hormone Deficiency ("AGHD"). Prescription Drug User Fee Act ("PDUFA") date set for November 5, 2014.
• Dennis Turpin, CFO of Aeterna Zentaris commented, "With our cash position, combined with the streamlining of our R&D activities, we are able to continue to advance our strategic programs and reach our near-term milestones related to Macrilen™ and zoptarelin doxorubicin."