FDA APPROVES JUBLIA FOR CHILDREN AGES 6 AND OLDER
posted: May 06, 2020.
Ortho Dermatologics has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) 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.
Dr. Tracey Vlahovic |
"Aside from being a cause of discolored toenails, onychomycosis may cause patients to experience nail discomfort in their shoes and during general activity. In certain populations, it can also potentially lead to a secondary infection," said Tracey Vlahovic, DPM, clinical professor, Department of Podiatric Medicine, and adjunct professor, Department of Microbiology, Temple University School of Medicine. "The expanded labeling for JUBLIA further demonstrates the safety and efficacy of this treatment option, which I look forward to adding to my treatment regimen for pediatric patients."
Source: Pharmacy Times [4/29/20]
Courtesy of Barry Block, editor of PM News