FDA accepts new drug application for DFD-29 for rosacea treatment
The FDA has accepted Journey Medical’s new drug application for DFD-29, a minocycline hydrochloride modified release capsule for rosacea treatment, setting a PDUFA date of Nov. 4. Supported by positive phase 3 trial data, DFD-29 aims to address both inflammatory lesions and erythema, potentially becoming a preferred treatment option.
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The FDA accepted Journey Medical's NDA for DFD-29, targeting rosacea treatment, with a PDUFA goal date of November 4, 2024. DFD-29, supported by positive Phase 3 trial data, aims to treat both inflammatory lesions and erythema, potentially becoming the preferred oral medication for rosacea.
The FDA has accepted Journey Medical’s new drug application for DFD-29, a minocycline hydrochloride modified release capsule for rosacea treatment, setting a PDUFA date of Nov. 4. Supported by positive phase 3 trial data, DFD-29 aims to address both inflammatory lesions and erythema, potentially becoming a preferred treatment option.
Emrosi, a low-dose minocycline hydrochloride extended-release capsule, was FDA approved on November 1, 2024, for treating rosacea's inflammatory lesions in adults. Supported by Phase 3 trials, it showed superiority over standard treatments. Warnings include skin reactions, tooth discoloration, and CNS side effects. Common adverse reaction is dyspepsia.
Journey Medical Corporation announced FDA acceptance of its NDA for DFD-29, targeting rosacea treatment, with a PDUFA goal date of November 4, 2024. DFD-29 showed superiority in Phase 3 trials over current treatments, aiming to address both inflammatory lesions and erythema in rosacea patients.