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FDA News Briefs for Monday, February 12, 2018

February 12, 2018

These Food and Drug Administration (FDA) developments came in last week:


FDA Approves New Once-Daily Single-Tablet Triple Regimen for HIV-1 Infection

On February 7, 2018, the FDA approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; Gilead Sciences, Inc.) to treat human immunodeficiency virus type 1 (HIV-1) in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. More Information.


FDA Deems Kratom An Opioid

The FDA released a statement this week claiming that compounds in kratom, a popular herbal substance, act like a prescription-strength opioid. The agency reports that kratom has now been linked to 44 deaths, up from 36 deaths reported in November 2017. More Information.


FDA Safety Update: Pentax Medical Duodenoscope Model ED-3490TK

The FDA issued a safety alert on Wednesday to provide updated status information about FDA clearance of a modified version of Pentax’s ED-3490TK. Pentax issued an urgent medical device correction and removal notification informing customers of its voluntary recall of all ED-3490TK duodenoscopes in order to replace the forceps elevator mechanism, O-ring seal and distal end cap, and to update the Operation Manual to recommend annual maintenance. The design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap. The FDA cleared the updated design and labeling for the ED-3490TK on February 7, 2018. The reprocessing instructions for the recently cleared ED-3490TK have not changed since the February 2016 update. More Information.