Supernus Provides Regulatory Update for SPN-830
Supernus receives a Complete Response Letter from FDA for SPN-830, an apomorphine infusion device for Parkinson’s disease, citing product quality and infusion device master file issues. No clinical safety or efficacy issues identified. Company remains committed to addressing the CRL and resubmitting the NDA.
Reference News
Supernus Provides Regulatory Update for SPN-830
Supernus receives a Complete Response Letter from FDA for SPN-830, an apomorphine infusion device for Parkinson’s disease, citing product quality and infusion device master file issues. No clinical safety or efficacy issues identified. Company remains committed to addressing the CRL and resubmitting the NDA.