FDA Alerts
Rapid Diagnostic Test to Detect Both HIV-1 Antigen and HIV-1/2 Antibodies
The US Food and Drug Administration today approved the first rapid human immunodeficiency virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens.
FDA Limits Usage of Nizoral (Ketoconazole) Oral Tablets
The US Food and Drug Administration (FDA) is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems and advising that it can lead to harmful drug interactions with other medications.
FDA Permits Marketing of First US Test Labeled for Simultaneous Detection of Tuberculosis Bacteria and Resistance to the Antibiotic Rifampin
The US Food and Drug Administration today allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for the treatment of TB.
FDA Approves Vibativ
The US Food and Drug Administration today expanded the approved use of the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus.
FDA Approves First Genotyping Test for Patients with Hepatitis C Virus
The US Food and Drug Administration today approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying.
FDA Releases New Tool to Help Prevent Intentional Food Contamination
The US Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination.
FDA Warns Consumers About Potential Health Risk with Juices Inc. Juice Products
The US Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y.
FDA Launches Partnership to Protect Against Counterfeit Anti-Malarial Medicines
The US Food and Drug Administration today announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3.
Rich Products Corporation Recalls Products for E. Coli Risk
Rich Products Corporation of Buffalo, New York, has announced a voluntary recall of certain Farm Rich ® and Market Day ® products.
FDA Approves TOBI Podhaler
The US Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.