Verrica Holds Type A Meeting With FDA For Potential Approval Of Skin Infection Candidate

The U.S. Food and Drug Administration (FDA) convened a Type A meeting with Verrica Pharmaceuticals VRCA regarding the course of action for the clearance of its drug candidate VP-102.

The Type A meeting was held on Jun 27th, 2022, in connection with the way forward for the resubmission and potential approval of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum).

Earlier, In the month of May 2022, FDA has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for VP-102, indicated deficiencies at general Reinspection of Sterling Pharmaceuticals Services, LLC.

Ted White, President and Chief Executive Officer, commented : "We are pleased with our communications with the FDA leading up to and during yesterday's Type A meeting, In particular, we are encouraged by the FDA's willingness to work collaboratively with us on the amount of stability data required from an alternative contract manufacturing organization (CMO) for our bulk solution at the time of resubmission as well as our options for post-approval use of bulk solution previously manufactured.”

Verrica shares are trading high 3 percent at $2.25

Posted In: FDA MeetingBiotechNewsPenny StocksHealth CareFDAGeneral

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