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Verrica’s Molluscum Product Set Back By FDA Usage Questions

 
• By Joseph Haas

Verrica got a complete response rather than approval for its drug/device combo for molluscum, but says the FDA only needs additional information on product changes for safe usage by clinicians.

Road_Safety_Barriers
Safe usage issues are the main factor delayiing approval of Verrica's molluscum product

Verrica Pharmaceuticals, Inc.reported that the complete response letter for its drug for molluscum contagiosum Ycanth (VP-102) raises no new issues about clinical efficacy or safety, but it still could push back the drug/device combination product’s approval timeline by a year or so.

The US Food and Drug Administration issued the CRL on Ycanth’s user fee date of 13 July, about two weeks...

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