29 April 2020 - Ortho Dermatologics today announced today announced the U.S. FDA has approved a supplemental new drug application for Jublia (efinaconazole) topical solution, 10%, a treatment for onychomycosis, a fungal infection of the toenails, which extends the age range included in the product's label to children six years of age and older.

Jublia was first approved in June 2014 in patients 18 years and older.

The safety, pharmacokinetics and efficacy of Jublia in patients ages six to 16 years old were evaluated in a multicenter, open-label, single-arm Phase 4 study that enrolled 62 patients with mild-to-severe onychomycosis.

Read Ortho Dermatologics press release