SUPN - Supernus Pharmaceuticals Faces Second FDA Rejection For Investigational Device For Parkinson's Disease | Benzinga
On Monday, Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) announced a regulatory update for SPN-830, an investigational apomorphine infusion device under FDA review for the continuous treatment of motor fluctuations (“off” episodes) in Parkinson’s disease (PD).
The FDA has issued a Complete Response Letter (CRL) in response to the company’s New Drug Application (NDA) for SPN-830.
The CRL indicates that the review cycle for the application is complete but that the application still needs to be prepared for approval in its present form.
The CRL mentions two areas that require additional review ...