Brief: Arcutis Provides Update on sNDA for Roflumilast Cream 0.15% for Atopic Dermatitis
09/07/2024 13:22
July 9 (Reuters) - Arcutis Biotherapeutics Inc ARQT.O :
* ARCUTIS PROVIDES UPDATE ON SNDA FOR ROFLUMILAST CREAM
0.15% FOR
ATOPIC DERMATITIS
* ARCUTIS BIOTHERAPEUTICS: HAS BEEN IN COMMUNICATION WITH
U.S FDA
. REGARDING ITS SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) FOR
ROFLUMILAST CREAM 0.15%
* ARCUTIS BIOTHERAPEUTICS: FDA INDICATED THAT THEY ARE
WORKING TO
FINALIZE ACTION LETTER & HAVE NOT INDICATED THEY WOULD EXTEND
PDUFA GOAL DATE OF JUL 7
Source text for Eikon: ID:nGNX9PyYnH
Further company coverage: ARQT.O
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