FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a bioMérieux 510(k) for the VIDAS 3 immunoassay analyzer. This newest version of the device features enhanced automation, improved traceability and new software capabilities, as well as a quality control program in compliance with laboratory certification standards, the company says.

Corvida Medical has received FDA 510(k) clearance for the Halo Closed System Transfer Device and its use to protect health care professionals from exposure to hazardous drugs. The device provides vapor and leak-proof connections between the components used in the compounding and administrative chemotherapy processes, according to the company. The components include drug vial adapters, syringe and line adapters, and bag spikes.

FDA has cleared NeuWave Medical’s Ablation Confirmation software integrated into the NeuWave Intelligent Ablation System. The company says that the clearance means that the “totality of the NeuWave System … gives physicians the first and only in-procedure confirmation of ablation.” Ablation Confirmation is described as a computed tomography image processing software package that assists doctors in identifying ablation targets, assessing proper ablation probe placement, and confirming ablation zones post-procedure.

HUMAN DRUGS

FDA has approved a Bayer HealthCare NDA for Finacea (azelaic acid 15%) Foam for topical treatment of inflammatory papules and pustules of mild to moderate rosacea.

Bristol-Myers Squibb has received FDA approval of its NDA for Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. “Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection,” an agency release says.

Strides Arcolab Ltd. has received approval from FDA for benzonatate capsules to treat common cold and cough.

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