Verrica Pharmaceuticals Refiles FDA Application for VP-102
November 29 2021 - 8:18AM
Dow Jones News
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)
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