By Colin Kellaher

 

Verrica Pharmaceuticals Inc. on Monday said it has resubmitted a new drug application for VP-102 to the U.S. Food and Drug Administration after the agency rejected the application for the company's lead product candidate in September.

The West Chester, Pa., dermatology therapeutics company, which is seeking approval of VP-102 for the treatment of viral skin disease molluscum contagiosum, said it believes the application qualifies as a class I resubmission, with a two-month review.

The FDA in September turned away Verrica's application for VP-102 after finding deficiencies at a facility of a contract manufacturing organization that weren't specifically related to the manufacturing of the drug but raised general quality issues at the plant.

Verrica said its resubmission is limited to those sections and elements of the application that the FDA identified as deficiencies.

Verrica said VP-102, if approved, would be the first product cleared by the FDA to treat molluscum contagiosum, adding that it is well-prepared to launch the drug-device combination, which it plans to market as Ycanth.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

November 29, 2021 08:03 ET (13:03 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.
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