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The FDA has issued a Complete Response Letter (CRL) regarding Verrica Pharmaceuticals Inc's (NASDAQ: VRCA) marketing application seeking approval for VP-102 for molluscum contagiosum, a highly contagious viral skin disease.
The FDA had previously extended the Prescription Drug User Fee Act (PDUFA) goal date for the application by three months.
The Agency needed additional time to review the information submitted in response to comments regarding the Company's human factors study.
According to the CRL, the FDA has identified deficiencies at a contract manufacturing organization (CMO) facility.
The issue is not specifically related to the manufacturing of VP-102 but instead raises general quality issues at the facility.
The FDA did not identify any clinical, safety, or product-specific Chemistry, Manufacturing, and Controls (CMC) deficiencies related to VP-102.
Verrica expects a resolution of the facility's identified deficiencies from the FDA within the next 30 business days.
Related content: Benzinga's Full FDA Calendar.
Price Action: VRCA stock is down 26.2% at $8.88 during the premarket session on the last check Tuesday.
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