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And other news from the US Food and Drug Administration
April 2016, Vol 4, No 4 - Inside Drug Update

New Drugs

The following are recent approvals announced by the US Food and Drug Administration (FDA):

  • Anthim (obiltoxaximab) injection has been approved by the FDA for use in combination with suitable antibacterial drugs in patients with inhalational anthrax. When other therapies are not available or appropriate, the injection can also be used to prevent inhalational anthrax. Headache, pruritus, upper respiratory tract infections, cough, nasal congestion, hives, and infusion site bruising, swelling, and pain were the most commonly reported adverse effects associated with the drug.
  • Idelvion, Coagulation Factor IX (recombinant), albumin fusion protein has received FDA approval for use in children and adults with hemophilia B. Along with being the first coagulation factor-albumin fusion protein product to be approved, Idelvion is the second factor IX fusion protein product modified to last longer in the blood that has been approved in the United States. Headaches were the most commonly reported adverse effects associated with the drug.

Announcements

  • The FDA recently announced a nationwide proposal to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves, thereby removing them from the marketplace entirely. Although powder is occasionally added to gloves to increase their ease of use, powdered gloves can pose a variety of risks; of note, aerosolized glove powder on natural rubber latex gloves can carry proteins that may cause respiratory allergic reactions. The organization asserts that, although use of powdered gloves is decreasing, they pose a significant, unreasonable risk of illness or injury to people exposed to them, and this cannot be remedied with new or updated labeling.
  • According to a recent announcement by the FDA, the organization has permitted promotion of the Triggerfish, a product that may help practitioners identify the best time of day to measure a patient’s intraocular pressure (IOP), which is associated with nerve damage common in glaucoma. A one-time-use, soft, silicone contact lens that detects tiny variations in an eye’s volume, the Triggerfish is worn for no longer than 24 hours, and wirelessly transmits data to an adhesive antenna worn around the eye. Indicated for use in patients aged ≥22 years under direct supervision of a healthcare professional, the Triggerfish device does not actually measure IOP, does not correct vision, and is not intended to be a diagnostic tool.



  1. US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements. Updated March 21, 2016. Accessed March 21, 2016.
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Last modified: April 24, 2016
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