FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved a Roche PMA for the cobas MPX test for use on the cobas 6800 and 8800 Systems. The test enables donor screening laboratories to “apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the United States, preventing the spread of Human Immunodeficiency Virus Groups 1 and 2 (HIV-1 and HIV-2), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through transfused blood products,” the company says.

FDA has cleared a Teleflex 510(k) to market its Arrow Midline with Chlorag+ard Technology, an anti-thrombogenic and antimicrobial peripheral venous catheter designed to minimize common midline catheter complications such as catheter intraluminal occlusion, thrombus accumulation and microbial colonization on the catheter surface for a minimum of 30 days.

Royal Philips has gained 510(k) clearance for the S4-1 cardiac transducer for Lumify, a“smart-device” diagnostic ultrasound product. The pocket-sized and lightweight device offers high-resolution 2D image quality and exam pre-sets to allow clinicians to quickly triage and assess their patients, the company says.

DRUGS

FDA has approved a Merck NDA for Zinplava (bezlotoxumab) injection 25 mg/mL, indicated for reducing recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment and are at high risk for CDI recurrence. The company notes that the therapy is not indicated for treating CDI, and it is not an antibacterial drug, which is why it should only be used in conjunction with antibacterial drug treatment.

FDA has approved an Astellas Pharma and Pfizer supplemental NDA to change product labeling for Xtandi (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. The data demonstrate improvement in radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer who were treated with enzalutamide compared to patients who were treated with bicalutamide, according to the companies.

FDA has approved Genentech’s Tecentriq (atezolizumab) for treating people with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.

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