Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device
Working closely with the U.S. Food and Drug Administration (FDA), Supernus believes it has addressed the FDA’s questions related to a Complete Response Letter (CRL) issued in October 2022 for the SPN-830 New Drug Application (NDA).
- Working closely with the U.S. Food and Drug Administration (FDA), Supernus believes it has addressed the FDA’s questions related to a Complete Response Letter (CRL) issued in October 2022 for the SPN-830 New Drug Application (NDA).
- The CRL required additional information and analysis related to the infusion device and drug product across several areas of the NDA.
- Supernus will continue to work closely with the FDA as it reviews the SPN-830 NDA.
- “SPN-830 represents a novel and less invasive therapy approach for PD patients who are seeking a convenient option in the form of a continuous subcutaneous infusion of apomorphine,” said Jack Khattar, President and CEO of Supernus.