FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a K2M Group Holdings 510(k) for its Ozark Cervical Plate Systems for anterior screw fixation to the cervical spine (C2-T1) in patients with degenerative disease, deformity, tumor, or trauma. The systems are available in two designs, Ozark Guide and Ozark View, both featuring an advanced per-level, integrated locking cover that provides surgeons with clear visual and tactile confirmation of the final lock position, the company says. They both include a full range of plate and screw sizes and instrumentation for creating constrained, semi-constrained or hybrid screw constructs, it adds.

FDA has cleared an Edap TMS 510(k) for its Focal One device for ablating prostate tissue. The high-intensity focused ultrasound device is the “first medical apparatus designed specifically for focal treatment of the prostate,” the company says. “Focal One fuses MR and 3D biopsy data with real-time ultrasound imaging, which allows urologists to view integrated, detailed 3D images of the prostate on a large monitor and direct high intensity ultrasound waves to ablate the targeted area,” it says. The device allows surgeons to map precise contours around diseased tissue and ablate small portions of the prostate to lessen damage healthy tissue and minimize side effects of incontinence and impotence for patients, the company adds.

DRUGS

FDA has approved an AbbVie’s Venclexta (venetoclax tablets) in combination with rituximab for treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Approval is based on MURANO Phase 3 clinical trial data which demonstrated a significant improvement in progression-free survival for relapsed/refractory CLL patients, “reducing the risk of disease progression or death by 81% when compared to bendamustine in combination with rituximab, a standard of care chemoimmunotherapy regimen,” the company says.

FDA has approved a Partner Therapeutics NDA for leukine for treating adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). The company notes that efficacy studies of Leukine could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons and approval of this use was based on government-sponsored efficacy studies conducted in animals.

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