Verrica Pharmaceuticals announced the FDA acceptance of the New Drug Application (NDA) resubmission for VP-102 (Verrica Pharmaceuticals) for the treatment of molluscum contagiosum.
Verrica Pharmaceuticals announced today that the FDA has acknowledged its resubmitted New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) was complete and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2022.
This comes after the FDA identified deficiencies at a manufacturing facility for VP-102. The PDUFA date for the drug had been extended previously for the NDA by 3 months to September 23, 2021, to allow the FDA more time to review information submitted by Verrica in response to comments from the agency regarding a human factors study.
“We are pleased that the FDA has accepted our NDA resubmission for VP-102,” said Ted White, president, and CEO of Verrica Pharmaceuticals in West Chester, Pennsylvania. “While we recognize the demands of the agency’s current workload, we intend to work with the FDA toward approval as quickly as possible based on the limited changes in our resubmission. We continue to be encouraged by the overwhelming demand from both caregivers and the medical community for an FDA-approved treatment for molluscum, one of the largest unmet needs in medical dermatology.”
1. Verrica Pharmaceuticals Inc Announces FDA accepts NDA resubmission for VP-102. StreetInsider.com. Published December 15, 2021. Accessed December 15, 2021. https://www.streetinsider.com/Corporate+News/Verrica+Pharmaceuticals+Inc.+%28VRCA%29+Announces+FDA+Accepts+NDA+Resubmission+for+VP-102/19356660.html