Brief: Calliditas Receives FDA Priority Review For Approval Of Tarpeyo

Calliditas Therapeutics AB

18/08/2023 11:05

Aug 18 (Reuters) - Calliditas Therapeutics AB
 CALTX.ST :
    * FDA GRANTS PRIORITY REVIEW FOR FULL APPROVAL OF TARPEYO
FOR THE
TREATMENT OF IGA NEPHROPATHY
    * FDA HAS ACCEPTED SUBMISSION FOR SUPPLEMENTAL NEW DRUG
APPLICATION (SNDA) FOR TARPEYO(®) (BUDESONIDE) DELAYED RELEASE
CAPSULES AND GRANTED PRIORITY REVIEW
    * PRESCRIPTION DRUG USER FEE ACT (PDUFA) GOAL DATE IS 20
DECEMBER
2023
    * CALLIDITAS THERAPEUTICS IS ALSO COLLABORATING WITH ITS
EUROPEAN
COMMERCIAL PARTNER, STADA ARZNEIMETTEL AG, TO SEEK FULL APPROVAL
OF NEFECON (WHICH RECEIVED CONDITIONAL APPROVAL UNDER BRAND NAME
KINPEYGO®) BY EUROPEAN COMMISSION IN FULL STUDY POPULATION

Source text for Eikon:  ID:nWkr3qxHyV 
Further company coverage:  CALTX.ST 

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