Brief: Hungary's Richter says its partner AbbVie submitted supplemental new drug application for Cariprazine in U.S.

Gedeon Richter

22/02/2022 13:34

BUDAPEST, Feb 22 (Reuters) - Hungary's Richter  GDRB.BU 
says:
    * ITS PARTNER ABBVIE TODAY ANNOUNCED THAT IT HAS SUBMITTED A
SUPPLEMENTAL NEW DRUG APPLICATION FOR CARIPRAZINE TO THE FDA IN
THE UNITED STATES
    * APPLICATION SUBMITTED FOR THE ADJUNCTIVE TREATMENT OF
MAJOR
DEPRESSIVE DISORDER IN PATIENTS WHO ARE RECEIVING ONGOING
ANTIDEPRESSANT THERAPY
    * SUBMISSION IS SUPPORTED BY RESULTS FROM PREVIOUSLY
ANNOUNCED
CLINICAL TRIALS 
    * IF APPROVED, THIS WILL BE FOURTH INDICATION FOR
CARIPRAZINE
    * CARIPRAZINE IS FDA-APPROVED AND MARKETED IN THE U.S. AS
VRAYLAR

Further company coverage:  GDRB.BU 

 (Reporting by Anita Komuves)
 ((KOMUVES.Anita@thomsonreuters.com;))