Brief: Supernus Pharmaceuticals Provides Regulatory Update On Spn-830

Supernus Pharmaceuticals

10/10/2022 13:37

Oct 10 (Reuters) - Supernus Pharmaceuticals Inc
 SUPN.O :
    * SUPERNUS PROVIDES REGULATORY UPDATE ON SPN-830
    * SUPERNUS PHARMACEUTICALS INC - TODAY ANNOUNCED THAT FDA
HAS
ISSUED A COMPLETE RESPONSE LETTER FOR SPN-830 NEW DRUG
APPLICATION
    * SUPERNUS PHARMACEUTICALS INC - CRL DOES NOT REQUEST
ADDITIONAL
EFFICACY AND SAFETY CLINICAL STUDIES
    * SUPERNUS PHARMACEUTICALS - CRL REQUIRES ADDITIONAL
INFORMATION
AND ANALYSIS RELATED TO INFUSION DEVICE AND DRUG PRODUCT ACROSS
SEVERAL AREAS OF NDA
    * SUPERNUS PHARMACEUTICALS - FDA MENTIONS APPROVAL OF NDA
REQUIRES
INSPECTIONS THAT COULD NOT BE COMPLETED IN TIMELY MANNER DUE TO
COVID-19 RESTRICTIONS
    * SUPERNUS - FDA MADE INITIAL DETERMINATION THAT AMENDMENT
TO CO'S
APPLICATION IN RESPONSE TO CRL WILL BE SUBJECT TO CLASS 2,
REVIEW TIMELINE

Source text for Eikon:  ID:nGNX5ZsH5y 
Further company coverage:  SUPN.O 
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