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Verrica Receives Complete Response Letter from the FDA for its NDA for VP-102 as a Direct Result of Deficiencies at General Reinspection of Sterling Pharmaceuticals Services, LLC
Verrica has been advised that PAI (Pre-Approval Inspection) was conducted at Sterling and is not aware of any reported observations related to the PAI of
About this update from Verrica Pharmaceuticals Inc.
[{"type":"text","content":"Verrica has been advised that PAI (Pre-Approval Inspection) was conducted at Sterling and is not aware of any reported observations related to the PAI of VP-102 operations Review Division had advised Verrica that the review of NDA was completed and label was ready to be communicated, except for Sterling’s classification status Verrica has been notified that Sterling is on OAI (Official Action Indicated) status WEST CHESTER, Pa., May 24, 2022 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum). The only deficiency listed in the CRL was related to the deficiencies identified at a general reinspection of Sterling Pharmaceuticals Services, LLC (Sterling), the contract manufacturing organization (CMO) that manufactures Verrica’s bulk solution drug product. Sterling advised Verrica on May 20, 2022 that it received notice that it is on OAI status. Sterling’s OAI classification resulted from a week-long reinspection of the CMO conducted by FDA in February 2022. The reinspection was conducted approximately 90 days after Sterling was originally classified by the Agency as VAI (Voluntary Action Indicated) on November 17, 2021. Verrica understood that the VAI classification did not indicate that a reinspection was required. The CRL did not identify any other deficiencies. Moreover, none of the issues identified by FDA during the reinspection were specific to the manufacturing of VP-102. Additionally, Verrica was informed by the Division that it had completed its review of Verrica’s NDA and product label, there were no open questions on the NDA review, and the VP-102 label was ready to be communicated. However, Verrica has been informed that internal FDA policy is preventing the Agency from communicating the label and approving the NDA when a CMO has an unresolved classification status or is placed on OAI status. “Based on the successful PAI of VP-102 at Sterling and our understanding that the Division was ready to communicate our label, we believe our NDA meets the statutory standards for approval a...