Verrica Pharmaceuticals (NASDAQ:VRCA) announces that it has received a letter from the FDA related to its review of the company’s marketing application seeking approval of lead candidate VP-102 (cantharidin 0.7% topical solution) for the treatment of molluscum contagiosum, a contagious viral infection characterized by small bumps on the skin.
The agency cites deficiencies that “preclude discussion of labeling and post-marketing requirements” at this time but, giving the company a ray of hope, states that it has not made a final decision on the matter. Its action date is July 13.
The company says the letter does not specify any particular items but it has noted that the agency’s periodic requests for additional information have pertained to chemistry, manufacturing and control (CMC) aspects of the drug-device combination, adding that its ability to address the requests have been “significantly impacted” by COVID-19 disruptions.
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