Cytori Reports Summary of FDA Feedback Regarding its ATI-1123 Product (GlobeNewswire, Cytori Therapeutics Inc.) - Jul 1, 2019 - CYTX) today provided an update on the development of its proprietary drug, ATI-1123, based on recently obtained feedback from the United States Food and Drug Administration (FDA). ATI-1123 is a substantially redesigned and reformulated new drug based in part, on the active pharmaceutical ingredient, docetaxel. Key feedback from the FDA included that a 505(b)(2) application appears to be an acceptable regulatory approach with docetaxel injection as a potentially acceptable LD.
Clinical • FDA event • NDA • P1 data • Regulatory
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