FDA issues Complete Response Letter to AP Pharma relating to AP F 530 for CINV

AP PHarma as announced that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for its lead product candidate, APF 530, for the prevention of Chemotherapy-induced Nausea and Vomiting (CINV). The FDA has requested the refinement of a product quality analytical test method, and that certain deficiencies identified during facility pre-approval inspections be addressed. The FDA has requested that a human factors validation study evaluating the usability of the APF 530 syringe system together with its proposed product labeling and instructions for use be conducted with product assembled using a validated, commercial process. The FDA has requested a re-analysis of the existing Phase III clinical data The FDA did not request any new clinical studies.