JHVEPhoto Arcutis ( NASDAQ: ARQT ) said Tuesday the FDA was still working on the action letter for its application to have its drug roflumilast cream 0.15% approved for the treatment of atopic dermatitis in patients aged 6 years or older. The biotech company said the FDA has not requested any additional information on the product related to the application.
The FDA has not indicated it intends to extend its target action goal date of July 7, Arcutis added. Arcutis already markets cream and foam formulations of roflumilast under the brand name Zoryve for the treatment of plaque psoriasis and seborrheic dermatitis. More on Arcutis Biotherapeutics Arcutis Stock: Sales Expansion Momentum Puts It On A Good Trajectory Arcutis Biotherapeutics, Inc.
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