Brief: Hungary's Richter says US FDA accepted for review its new drug application for Fylrevy

Gedeon Richter

14/10/2026 07:04

Oct 14 (Reuters) - Hungary's Gedeon Richter Plc. GDRB.BU says in a staement:
US FOOD AND DRUG ADMINISTRATION ACCEPTED FOR REVIEW ITS NEW DRUG APPLICATION FOR FYLREVY
FDA IS EXPECTED TO COMPLETE ITS REVIEW BY Q3 2027
FYLREVY IS AN ORALLY ADMINISTERED ESTETROL-BASED OESTROGEN THERAPY DESIGNED TO TREAT MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE
IN MARCH 2026 FYLREVY WAS GRANTED MARKETING AUTHORIZATION BY THE EUROPEAN COMMISSION 
TO DATE, FYLREVY IS COMMERCIALIZED IN HUNGARY, CZECH REPUBLIC, SLOVAKIA, FINLAND AND SWEDEN  
Source text: [https://www.bse.hu/newkibdata/129550636/Fylrevy_FDA_submission_Oct2026_EN.pdf]
Further company coverage: GDRB.BU

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