AdventRx submits approval application for chemotherapy drug
SAN DIEGO A drug maker in Southern California plans to submit an approval application for a new chemotherapy drug by the end of the year.
AdventRx Pharmaceuticals announced Tuesday that it would submit a new drug application to the Food and Drug Administration for its chemotherapy emulsion ANX-530 (vinorelbine).
“Our recently completed manufacturing activities represented the last major hurdle before our NDA submission,” AdventRx principal executive officer Brian Culley said in a statement. “While we continue to evaluate the bioequivalence and preclinical data, we have begun the substantial process of compiling the information required for a submission, which we expect to take place by the end of this year.”