Drugs

Verrica Pharma NDA Resubmitted for Skin Infection

FDA has accepted for review a Verrica Pharmaceuticals NDA resubmission for VP-102 to treat molluscum contagiosum, described by the Centers for Disease Control as an infection caused by a virus. The result of the infection is usually a benign, mild skin disease characterized by lesions that may appear anywhere on the body. The agency has set a 7/23 user fee review action target date.

Last May, the agency issued a complete response letter on an earlier NDA submission, which the company says cited deficiencies found in a reinspection of Sterline Pharmaceutical Services, the contract manufacturer for Verrica’s bulk solution drug product. After a meeting with FDA in June, the company was told that an NDA resubmission would not be permitted with Sterling listed as the primary manufacturer while it was on “official action indicated” status. “Following the FDA's commentary, we selected a new [contract manufacturer] partner to produce the bulk solution, Piramal Pharma Solutions, and the technology transfer process is on-going,” Verrica says.

VP-102 is described by the company as a proprietary drug-device combination product that contains cantharidin, which is delivered via a single-use applicator that allows for precise topical dosing and targeted administration. Recently, Verrica says it has successfully completed a Phase 2 study of VP-102 for treating common warts and another Phase 2 study for treating external genital warts.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome