FDA Policy/General

Product Approval Summaries

DEVICES

Instrumentation Laboratory has received FDA 510(k) clearance of its ACL TOP Family 50 Series Hemostasis Testing Systems for mid- to-high-volume clinical laboratories, including those using lab automation tracks. According to the company, the systems offer automated pre-analytical sample integrity checks which identify under-filled sample tubes, abnormal sample aspiration potentially caused by clots, and assay-specific interference from hemolysis, icterus and lipemia. It also says the systems offer enhanced laboratory accreditation tools to automate documentation for compliance with quality standards.

Roche has received FDA approval for the cobas HIV-1 viral load test for use on the cobas 6800 and cobas 8800 Systems. The company says this HIV-1 viral load test is part of the next generation of Roche viral load tests.

HUMAN DRUGS

FDA has approved Actelion Pharmaceticals’ Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH). An agency news release says the drug is an oral IP prostacyclin receptor agonist that acts by relaxing muscles in blood vessel walls to dilate the blood vessels and decrese the elevated pressure in the vessels supplying blood to the lungs.

FDA has approved AstraZeneca’s Zurampic (lesinurad) to treat hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor. An agency news release says the drug works by helping the kidney excrete uric acid. It does this, FDA says, by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.

Teikoku Pharma USA, Inc. has received FDA approval of docetaxel injection, non-alcohol formula for treating breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

VETERINARY

FDA has approved a supplemental NADA filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle.

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