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late-breaking news in healthcare

FDA News Briefs for Monday, January 22, 2018

January 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.