Verrica Pharmaceuticals receives complete response letter from the FDA identifying deficiencies at a facility of a contract manufacturer for its new drug application for VP-102 for the treatment of molluscum contagiosum

Verrica Pharmaceuticals

20 September 2021 - No specific deficiencies related to the manufacturing of VP-102 identified by FDA in its general inspection of a facility of the contract manufacturer.

Verrica Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding its new drug application for VP-102 for the treatment of molluscum contagiosum (molluscum). 

The Company had previously disclosed that the FDA extended the Prescription Drug User Fee Act goal date for the new drug application by three months to 23 September 2021 to allow the Agency additional time to review information submitted by the Company in response to comments from the Agency regarding the Company’s human factors study.

Read Verrica Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US