New Drugs/Devices
The following are some of the recent approvals announced by the US Food and Drug Administration (FDA):
- Zarxio (filgrastim-sndz) is the first biosimilar product approved in the United States. The drug is biosimilar to Amgen Inc’s Neupogen (filgrastim), and is approved for the same indications, including patients with severe neutropenia.
- Cresemba (isavuconazonium sulfate), a new intravenous antifungal product, was approved for adult patients with invasive aspergillosis and invasive mucormycosis. The drug belongs to a class of drugs called azole antifungal agents, which target the cell membrane of a fungus.
- Avycaz (ceftazidime-avibactam) is a new intravenous antibacterial drug product approved to treat adult patients with complicated abdominal infections, in combination with metronidazole, and patients with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative treatment options.
- ResQCPR System, a system of 2 devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on patients who are experiencing cardiac arrest, was approved. The device may improve the patient’s chances of surviving cardiac arrest.
New Generic
The following is a recent first-time generic drug approval by the FDA:
- The first generic version of Fusilev (levoleucovorin calcium; Spectrum Pharmaceuticals, Inc) for injection has been approved by the FDA. The generic drug name is levoleucovorin calcium injection, 10 mg/mL, and is manufactured by Sandoz, Inc.
New Rulings, Announcements
The following are some recent FDA rulings and announcements:
- US v Specialty Compounding LLC, et al. US District Judge Lee Yeakel entered a consent decree of permanent injunction between the United States and Specialty Compounding LLC, of Cedar Park, TX, and co-owners. Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. The consent decree prohibits the company and its owners from manufacturing, holding, or distributing sterile drugs until they comply with the Federal Food, Drug, and Cosmetic Act and its regulations, in addition to other requirements.
Sources
- US Food and Drug Administration. New and generic drug approvals. www.fda.gov/Drugs/NewsEvents/ucm130961.htm. Updated March 17, 2015. Accessed March 18, 2015
- US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/News room/PressAnnouncements/default.htm. Updated March 17, 2015. Accessed March 18, 2015.