Today the U.S. Food and Drug Administration allowed marketing of four diagnostic devices that can be used for high throughput gene sequencing, often referred to as “next generation sequencing” (NGS). These instruments, reagents, and test systems allow labs to sequence a patient’s DNA (deoxyribonucleic acid).
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, Inc., located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent. The retail value of the seized products is more than $2 million.
The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.
The U.S. Food and Drug Administration today approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.
The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability […]
A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.
The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
The U.S. Food and Drug Administration announced its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in food. The FDA’s preliminary determination is based on available scientific evidence and the findings of expert scientific panels.
On behalf of the U.S. Food and Drug Administration, the U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion […]
The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
The U.S. Food and Drug Administration is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order on reducing drug shortages, the number of new […]
The U.S. Food and Drug Administration today issued a proposed rule under the FDA Food Safety Modernization Act (FSMA) aimed at improving the safety of food for animals.
The U.S. Food and Drug Administration today approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer’s disease (AD) and dementia.
The U.S. Food and Drug Administration today approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.
The U.S. Food and Drug Administration is alerting hospitals, health care providers, veterinarians, and patients of a voluntary recall of certain human and veterinary products produced and distributed for sterile use by Specialty Medicine Compounding Pharmacy of South Lyon, Mich.
The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing out the worldwide production of numerous substances, including CFCs, which contribute to ozone depletion.
The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.
The U.S. Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in […]