Aeterna Zentaris Requests Fast Track Designation from the FDA for AEZS-130 as Diagnostic Test for Adult Growth Hormone Deficiency
Aeterna Zentaris Inc. (NASDAQ: AEZS) today announced that it has filed a request with the United States Food and Drug Administration (FDA) for Fast Track designation for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD). The request is part of the Company's New Drug Application strategy for AEZS-130 to advance the product towards regulatory approval as efficiently as possible.
The FDA's Fast Track program is designed, among other things, to facilitate the development and expedite the review of new drugs that demonstrate the potential to address unmet medical needs. According to its guidance on Fast Track applications, the FDA responds within 60 days of receipt of such requests.
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