FDA Policy/General

Product Approval Summaries

BIOLOGICS

FDA has approved Sandoz’s Zarxio (filgrastim-sndz), a copy of Amgen’s Neupogen (filgrastim), indicated for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.

DEVICES

FDA has cleared a Life Spine 510(k) for 40 spinal implant additions to the Conquest, Avatar, And Nautilus Thoracolumbar Screw Systems and Solstice Occipito-Cervico-Thoracic System. The clearance includes a variety of domino, in-line, and wedding band rod-to-rod connectors, open and closed offsets, and U-shaped connectors that allow for a rigid connection while skipping levels or mating with existing implants, the company says. “The addition of the various rod connectors can make revision surgery easier, safer, and quicker for both the patient and surgeon,” it says. “This enables potential faster recovery times and as a result, decrease post-operative pain.”

HUMAN DRUGS

FDA has approved Astellas Pharma U.S.’s Cresemba (isavuconazonium sulfate), an antifungal drug for adults with invasive aspergillosis and mucormycosis, caused by the Aspergillus species and the Mucorales fungi respectively. According to an FDA news release, Cresemba is an azole antifungal agent, which targets the cell wall of the fungus and is available in oral and intravenous formulations.

FDA has expanded the approved use of Bristol-Myers Squibb’s Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.

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