Drugs

Valeant Getting VAI Inspection Outcome at Tampa Facility

FDA has told Valeant Pharmaceuticals that it intends to issue a Voluntary Action Indicated (VAI) inspection classification for its Bausch + Lomb manufacturing facility in Tampa, FL as part of a forthcoming Establishment Inspection Report for the facility. “With this confirmation, manufacturing uncertainties related to current and upcoming regulatory submissions will be eliminated for products manufactured at the Tampa facility,” the company says.

Earlier this month, the agency issued Valeant Pharmaceuticals a complete response letter on its NDA for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure-lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The letter cited a GMP inspection at the manufacturing facility in Tampa, FL, according to Valeant. FDA did not identify any efficacy or safety concerns with the NDA or additional clinical trials needed for approval, it said at the time.

“Following continued close collaboration with FDA inspectors, today, the FDA confirmed that all issues related to a Current Good Manufacturing Practice inspection at the Tampa facility are being satisfactorily resolved, and VAI status will soon be granted to the facility,” the company now says. “As further evidence of the progress made at the Tampa facility, the Company received approval yesterday for a Supplemental New Drug Application for the facility to be a release testing facility for drug substance for Alaway (ketotifen fumarate ophthalmic solution), 0.035%.”

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