Novartis today announced the Complete Response resubmission to the US Food and Drug Administration (FDA) for the inclisiran New Drug Application (NDA). Novartis is listing its own site in Schaftenau, Austria, as the manufacturing location for the final finished product within the resubmission.

• The inclisiran Complete Response resubmission addresses the FDA Complete Response Letter (CRL) issued in December 2020, stating unresolved facility inspection-related conditions at a third-party manufacturing facility. The FDA did not raise any concerns related to the efficacy or safety of …