Aeterna Zentari expects to document AEZS-130 NDA with FDA for adult growth hormone deficiency Aeterna Zentaris Inc canadian generic tadalafil . Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, Although the FDA’s decision won’t allow us to submit our New Drug Program on a rolling basis, it ought not to influence the timing of our submitting of the NDA for AEZS-130, which is certainly expected early following year, nor if the potential be suffering from it of obtaining concern review. We are pursuing our strategy to advance AEZS-130 towards regulatory actively approval for AGHD, since it could become the first orally administered test in this indication.
AEZS-108 happens to be in a Phase 2 trial in advanced advanced and ovarian endometrial malignancy in Europe. Juergen Engel, Ph. D., President and CEO of Aeterna Zentaris mentioned, We are very happy with AEZS-108 gaining orphan-medication designation for ovarian tumor from the FDA as it would offer it with extra marketplace exclusivity protection. We look forward to reporting the final outcomes from our ongoing European Phase 2 study in ovarian and endometrial tumor, later this year. .. Aeterna Zentaris granted FDA orphan-drug designation for AEZS-108 in ovarian cancer Aeterna Zentaris Inc. , a late-stage drug development company specialized in oncology and endocrinology, announced that it has received from the U today.S. Food and Medication Administration , orphan-drug designation for AEZS-108, its doxorubicin targeted conjugate compound, for the treatment of ovarian cancer.