FDA News Briefs for Monday, January 22, 2018January 22, 2018
These Food and Drug Administration (FDA) developments came in late last week:
FDA Expands Approval of Qiagen Companion Diagnostic
The FDA has approved a premarket approval (PMA) supplement extending the indications for use of Qiagen’s therascreen EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Gilotrif (afatinib; Boehringer Ingelheim) for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor receptor (EGFR) mutations. More Information.
Safety Alert: Recall of Auromedics Levofloxacin Infusion
The FDA announced a voluntary nationwide recall of levofloxacin in 5% dextrose 250mg/50mL (AuroMedics Pharma LLC) due to presence of visible particulate matter tentatively identified as mold. More Information.