Arcutis Biotherapeutics said the FDA accepted its supplemental New Drug Application for ZORYVE (roflumilast) cream 0.05% to expand the drug’s atopic dermatitis indication to include mild to moderate disease. The acceptance of the sNDA is a positive regulatory milestone that could support broader commercial potential. No financial figures or timeline outcomes were provided in the excerpt.
Arcutis Biotherapeutics said the FDA accepted its supplemental New Drug Application for ZORYVE (roflumilast) cream 0.05% to expand the drug’s atopic dermatitis indication to include mild to moderate disease. The acceptance of the sNDA is a positive regulatory milestone that could support broader commercial potential. No financial figures or timeline outcomes were provided in the excerpt.
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