FDA Alerts
FDA Approves Xgeva
The US Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
FDA Approves Lenalidomide
On June 5, 2013, the US Food and Drug Administration approved lenalidomide capsules (REVLIMID, Celgene Corporation), for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor
The US Food and Drug Administration (FDA) is advising healthcare professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women.
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer
The US Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
FDA Announces Import of Injectable Nutrition Drugs
The US Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
FDA Clears First Blood Tracking Device That Uses Radio Frequency Identification Technology
iTrace for Blood Centers, the first application to use Radio Frequency Identification (RFID) technology in blood establishments to assist in enhancing blood safety by preventing the release of unsuitable blood components, was cleared today by the US Food and Drug Administration.
FDA Alerts Regarding Steroid Injections from Main Street Family Pharmacy
The US Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.
FDA Allows Marketing of First A1c Test Labeled for Diagnosing Diabetes
Today the US Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by healthcare professionals.
USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials
Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its methotrexate sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer.
FDA approves Simponi
The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.