FDA News Briefs for Tuesday, February 13, 2018February 13, 2018
These Food and Drug Administration (FDA) developments came in late last week:
FDA Expands Approval of Zytiga for High-Risk Prostate Cancer
The FDA has approved Zytiga (abiraterone acetate; Janssen Biotech) in combination with prednisone for high-risk castration-sensitive prostate cancer. Zytiga was previously approved for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. More Information.
FDA Approves Symfi Lo for Treatment of HIV-1
The Food and Drug Administration (FDA) has approved Symfi Lo (efavirenz, lamivudine, tenofovir disoproxil fumarate; Mylan) as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥ 35kg. More Information.
FDA Safety Alert: Philips HeartStart MRx Defibrillator Recall
Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device’s gas discharge tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device’s designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode. As a result of this GDT defect, the HeartStart MRx may fail at any time, including when delivering repeated shocks in AED mode, or during the periodic operational check outlined in the device’s instructions for use. More Information.