FDA accepts NDA for roflumilast foam 0.3% for the treatment of seborrheic dermatitis

The application was assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.

“Seborrheic dermatitis has long been a disease in need of its own treatment,” said Neal Bhatia MD, Director of Clinical Dermatology at Therapeutics Clinical Research and one of the investigators for Arcutis. “Some of the biggest challenges of current treatments have not only been lack of efficacy and consequences from long-term use, but also the limitations that affect adherence, especially the inability to treat both hair- and non-hair-bearing areas. Roflumilast foam was designed to address these shortcomings, as a once-daily, steroid-free topical drug that can be used chronically anywhere on the body. Dermatologists will be excited to incorporate roflumilast foam, if approved, as a new standard of care for those living with seborrheic dermatitis.”