FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a Globus Medical 510(k) for the Excelsius GPS, a robotic guidance and navigation system for orthopedic (screw placement applications in spine and orthopedic surgery) and neurosurgical procedures. The device integrates Globus Medical implants and instruments and is compatible with pre-operative computed tomography (CT), intra-operative CT and fluoroscopic imaging modalities, according to the company.

FDA has cleared a Stryker 510(k) for the Serrato Pedicle Screw, intended for use in the non-cervical spine as part of the company’s Xia 3 Spinal System. The device features serrated cutting flutes, a dual-thread pattern with an increased number of leads for rapid insertion, and a patented buttress thread locking mechanism designed to minimize cross threading and splaying of the screw head, according to the company.

DRUGS

FDA has approved an AstraZeneca NDA for Lynparza (olaparib) and its use as a maintenance treatment in adults with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status.

FDA has approved Wyeth Pharmaceuticals’ Besponsa (inotuzumab ozogamicin) for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval was based on data from INO-VATE ALL (NCT01564784), a randomized (1:1), open label, international, multicenter study in 326 patients with Philadelphia chromosome-negative or Philadelphia chromosome-positive relapsed or refractory B-cell precursor ALL.

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