Brief: ARS Pharmaceuticals Submits Response To FDA Complete Response Letter For neffy (Epinephrine Nasal Spray)

ARS Pharmaceuticals

03/04/2024 15:23

April 3 (Reuters) - ARS Pharmaceuticals Inc  SPRY.O :
    * ARS PHARMACEUTICALS SUBMITS RESPONSE TO FDA COMPLETE
RESPONSE
LETTER FOR NEFFY® (EPINEPHRINE NASAL SPRAY)
    * ARS PHARMACEUTICALS INC - SUBMISSION OF CRL RESPONSE
TRIGGERS UP
TO SIX-MONTH REVIEW PERIOD BY FDA
    * ARS PHARMACEUTICALS INC - ARS PHARMA ANTICIPATES AN FDA
REVIEW
PERIOD OF UP TO SIX MONTHS, AND PDUFA DATE IS ANTICIPATED TO BE
OCTOBER 2, 2024
    * ARS PHARMACEUTICALS INC - RESPONSE ADDRESSES ALL
ADDITIONAL
REQUESTS IN FDA CRL

Source text for Eikon:  ID:nGNX7Dkrl4 
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