Brief: Mithra Gets Guidance From FDA For Donesta® NDA Marketing Authorization Filing In US

Mithra Pharmaceuticals SA

30/11/2023 06:31

Nov 30 (Reuters) - Mithra Pharmaceuticals Sa  MITRA.BR :
    * MITHRA RECEIVES GUIDANCE FROM THE FDA FOR THE DONESTA® NDA
MARKETING AUTHORIZATION FILING IN THE UNITED STATES
    * SAYS FOLLOWING FDA ADVICE, PREPARATION OF FILING IS
PROCEEDING
WITH A FILING DATE NOW PLANNED IN Q4 2024
    * SAYS AGREEMENT FOR US COMMERCIALIZATION PARTNER FOR
DONESTA(®)
NOW EXPECTED DURING 2024
    * SAYS FDA MARKETING AUTHORIZATION, CONTINGENT UPON
SUCCESSFUL
COMPLETION OF APPROVAL PROCESS, NOW EXPECTED IN Q4 2025
    * TO SEEK DONESTA APPROVAL IN US AND EUROPE FOR TREATMENT OF
VASOMOTOR SYMPTOMS OF MENOPAUSE; SUBMISSION DATE FOR EMA FILING
IN Q4 2024

Source text for Eikon:  ID:nGNE6j5mVc 
Further company coverage:  MITRA.BR 

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