FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved a Hologic PMA for the Aptima HBV Quant Assay for calculating hepatitis B viral load on the fully automated Panther system. The assay offers a unique, dual-target approach that delivers “accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome,” the company says. The new product joins previously approved Aptima HIV-1 Quant Assay (for human immunodeficiency virus) and Aptima HCV Quant Dx Assay (for hepatitis C virus) on the Panther system. All three assays use Hologic’s real-time transcription-mediated amplification.

FDA has cleared a Medrobotics Corp. 510(k) for expanding the use of the Flex Robotic System for robot-assisted visualization in general surgical, gynecological and thoracic procedures. “This clearance is a vital step in our commitment to minimize the impact of surgery by offering less invasive procedures through a single incision in the abdomen or thoracic cavity versus the multiple incisions that are currently required,” the company says. The device was previously marketed for providing access to hard-to-reach anatomy in otolaryngology and colorectal procedures. Medrobotics says it is also pursuing expansion of applications to other areas including transvaginal gynecologic procedures.

FDA has cleared a Hitachi 510(k) for its Real Time Image Gating System for Proton Beam Therapy Systems for treating cancer patients. The device uses proprietary technology to track and irradiate tumors in motion. “This is accomplished by positioning a gold marker 2mm in diameter, close to the tumor and establishing its location as a reference via computed tomography,” the company says. “A dual-axis, orthogonal X-ray system is used with pattern recognition software to determine the spatial location of the marker due to respiration.

DRUGS

FDA has approved a Synergy Pharmaceuticals NDA for Trulance (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. The drug was previously approved for treating adults with chronic idiopathic constipation (CIC).

FDA has approved an Advanced Accelerator Applications NDA for Lutathera (lutetium Lu 177 dotatate) for treating gastroenteropancreatic neuroendocrine tumors. The agency says this is the first radiopharmaceutical approved for treating the tumors. The drug works by binding to a part of a cell called a somatostatin receptor, which may be present on certain tumors. After binding to the receptor, the drug enters the cell allowing radiation to cause damage to the tumor cells.

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