AuroMedics Pharma LLC – FDA CRL

The Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to AuroMedics Pharma LLC regarding its New Drug Application (NDA 210735) for Cyclophosphamide Solution. The application, submitted under section 505(b)(2), could not be approved due to significant product quality issues and unresolved manufacturing facility deficiencies.

The primary product quality concern involves the detection of visible particulate matter in the 1g configuration of the drug at 24 months, which the FDA believes was due to an inadequate initial inspection procedure. This inadequacy invalidated prior release and stability data, with three registration batches failing the visible particulate matter test. The agency also noted potential quality issues related to the manufacturing process and stoppers as sources of these particles.

Required actions include providing detailed analytical procedures for inspection methods, demonstrating improved detection capability, and resolving manufacturing process issues. AuroMedics must manufacture three new registration batches for both 1g and 500mg strengths, utilizing a compatible manufacturing process and providing comprehensive stability data. Furthermore, satisfactory resolution of deficiencies identified during a recent inspection of the manufacturing facility is mandatory. The company must also revise container and carton labels to include dehydrated alcohol amounts, update prescribing information to current regulatory standards, and submit a detailed safety update with comprehensive clinical data.