• The U.S. Food and Drug Administration approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test for the treatment of delayed gastric emptying, known as gastroparesis. Gastroparesis is a condition in which your stomach cannot empty itself of food in a normal fashion. It is caused by damage to the vagus nerve, which regulates the digestive system. A damaged vagus nerve prevents the muscles in the stomach and intestine from functioning, preventing food from moving through the digestive system properly. If this left untreated, gastroparesis can lead to problems such as severe dehydration due to persistent vomiting, difficulty managing blood sugar levels in people with diabetes, and malnutrition due to poor absorption of nutrients or a low caloric intake.

  • The US Food and Drug Administration (FDA) has approved the VenaSeal closure system, first device to permanently treat varicose veins of leg by sealing them with an adhesive agent. The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina.

  • The U.S. Food and Drug Administration granted approval to  Savaysa (edoxaban tablets) as anticlotting drug. This drug is used to reduce dangerous blood clots in patients with atrial fibrillation, deep vein thrombosis  and pulmonary embolism.

  • The Food and Drug Administration (FDA) is insisting the regulations in this regard are strictly followed. This ensures the products that come into the US are of the highest quality, have safety built into them and are effective. The US Food and Drug Administration (FDA) is increasing the frequency of inspections in India.

  • Novo Nordisk today announced the company will launch Novoeight® (Antihemophilic Factor [Recombinant]) in the United States for people living with hemophilia A. Novoeight® offers purity, reliability, and enhanced portability, with the highest storage temperature for the longest period of time compared with other marketed recombinant Factor VIII products—up to 86 degrees F for 12 months. It can be kept at that temperature for up to 4 hours after reconstitution, giving it the longest postreconstitution storage time. Novoeight® offers purity through a 5-step purification process. It was shown to be safe and effective in clinical trials with zero inhibitors confirmed in 213 previously treated patients with hemophilia A. Novo Nordisk plans to make Novoeight® available by mid-April 2015.

  • The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.

  • U. S. Food and Drug Administration granted accelerated approval to palbociclib (IBRANCE, Pfizer, Inc.) for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.

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  • USFDA approves first-of-kind device to treat obesity - VBLOC

    The U.S. Food and Drug Administration today approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.
    The Maestro Rechargeable System, the first FDA-approved obesity device since 2007, is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes.

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