FDA News Briefs for Thursday, June 20, 2019June 20, 2019
These Food and Drug Administration (FDA) developments came in this week:
FDA Updated Labeling for Biktarvy to Include Pediatric Patients with HIV-1
The FDA has approved updated labeling for Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide; Gilead Sciences Inc.). This single-tablet regimen is now approved to treat human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing ≥ 25 kg who have no antiretroviral treatment history or to replace current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 3 months on stable therapy with no history of treatment failure. Biktarvy was previously approved for adult patients. More Information.
Advance Enforcer 35 Focal-Force PTA Balloon Catheter Recalled
Cook Incorporation has issued a recall for the Advance Enforcer 35 Focal-Force PTA (percutaneous transluminal angioplasty) Balloon Catheter due to balloons bursting below the rated burst pressure. The FDA identified this a Class I recall as it may cause serious injuries or death. More Information.
Giraffe and Panda iRes Warmers Recalled
GE Healthcare has issued a recall for Giraffe and Panda iRes Warmers as bedside panels and latch areas on the beds may crack, break, or become damaged if the unit is not properly used. As part of this voluntary field corrective action, the manufacturer will replace cracked or damaged bedside panels or latches for Giraffe and Panda iRes Warmers as well as provide additional safety labels and posters. More Information.