Brief: US FDA Declines To approve Supernus' Drug-device Combination For Parkinson's Disease

Supernus Pharmaceuticals

08/04/2024 14:24

April 8 (Reuters) - Supernus Pharmaceuticals Inc
 SUPN.O :
    * SUPERNUS PROVIDES REGULATORY UPDATE FOR SPN-830
    * SUPERNUS PHARMACEUTICALS INC: FDA HAS ISSUED CRL IN
RESPONSE TO
COMPANY'S NEW DRUG APPLICATION (NDA) FOR SPN-830
    * SUPERNUS: CRL INDICATES REVIEW CYCLE FOR APPLICATION
COMPLETE,
BUT APPLICATION NOT READY FOR APPROVAL IN PRESENT FORM
    * SUPERNUS: ADDITIONAL INFORMATION TO BE PROVIDED TO FDA
WHICH
RELATES TO PRODUCT QUALITY, MASTER FILE FOR INFUSION DEVICE

Source text for Eikon:  ID:nGNX73kQxL 
Further company coverage:  SUPN.O 

 ((Reuters.Briefs@thomsonreuters.com;))