FDA approves new orphan drug for chronic myelogenous leukemia
Today the U.S. Food and Drug Administration approved Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults.
Archive for the ‘Drug Safety Information Podcasts’ category
FDA approves new treatment for a type of late stage prostate cancer
The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.
FDA approves Linzess to treat certain cases of irritable bowel syndrome and constipation
The U.S. Food and Drug Administration today approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults.
FDA approves new treatment for severe neutropenia in certain cancer patients
The U.S. Food and Drug Administration today approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.
FDA approves first drug formulated for children with rare brain tumor
The U.S. Food and Drug Administration today approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA). Afinitor Disperz is the first approved pediatric-specific dosage form developed for the treatment of a pediatric […]
FDA approves new combination pill for HIV treatment for some patients
The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.
FDA: U.S. Marshals seize food products at Fremont, Calif., warehouse
U.S. Marshals have seized food products stored in a Fremont, Calif., company’s warehouse after inspectors from the U.S. Food and Drug Administration found widespread and active rodent infestation.
FDA announces recall of cantaloupe by Chamberlain Farms of Owensville Indiana
• The U.S. Food and Drug Administration is announcing a recall of cantaloupe by Chamberlain Farms, of Owensville, Indiana, because of possible contamination with Salmonella Typhimurium associated with a multi-state outbreak of salmonellosis
FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium
The U.S. Food and Drug Administration today issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not […]
FDA approves first generic Actos to treat type 2 diabetes
The U.S. Food and Drug Administration today approved the first generic version of Actos (pioglitazone hydrochloride) tablets. Along with diet and exercise, pioglitazone is used to improve blood glucose control in adults with type 2 diabetes.
FDA recommends X-ray or other imaging on implanted heart defibrillators with St. Jude Medical Riata leads to help guide treatment
The U.S. Food and Drug Administration recommended today that patients who have implantable heart defibrillators with Riata and Riata ST leads, manufactured by St. Jude Medical, should have X-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the lead, which is a wire attached to the device that is inserted into […]
FDA warns of risk of death from codeine use in some children following surgeries
The U.S. Food and Drug Administration today issued a Drug Safety Communication concerning three children who died and one child who experienced a non-fatal but life-threatening case of respiratory depression after taking the pain reliever codeine following surgery to remove tonsils (tonsillectomy) and/or adenoids (adenoidectomy).
FDA approves vaccines for the 2012-2013 influenza season
The U.S. Food and Drug Administration announced today that it has approved the 2012-2013 influenza (flu) vaccine formulation for all six manufacturers licensed to produce and distribute the vaccines in the United States.
FDA approves Lucentis to treat diabetic macular edema
The U.S. Food and Drug Administration today approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.
FDA approves Marqibo to treat rare type of leukemia
The U.S. Food and Drug Administration today approved Marqibo (vincristine sulfate liposome injection) to treat adults with a rare type of leukemia called Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).
FDA revises safety information and limits use of Stryker Wingspan brain stent system
The U.S. Food and Drug Administration today approved changes to the labeling for the Stryker Wingspan Stent System, including the indications for use. These changes, which the FDA outlined in a safety communication also issued today, specify a more limited group of patients who may benefit from the system. In addition, the safety communication also […]
FDA approves Zaltrap for metastatic colorectal cancer
The U.S. Food and Drug Administration today approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.
FDA approves first generic versions of Singulair to treat asthma, allergies
The U.S. Food and Drug Administration today approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.
Food Safety Guides for Groups Most Vulnerable to Foodborne Illness Now Available
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) and the Department of Health and Human Services’ Food and Drug Administration (FDA) have partnered to create six booklets with food safety advice for populations that are most susceptible to foodborne illness. The booklets in this “at-risk series” are tailored to help older adults, […]