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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-106/
- Published: 2019-09-02T12:00:00.000Z
- Updated: 2026-09-15T01:47:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5131435

**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.