Latest Fda Approved Drugs Information Systems

(Reuters) Aug 28 - The U.S. Food and Drug Administration (FDA) said Sanofi's rare disease division, Genzyme, voluntarily recalled nine lots of its drug Thymoglobulin (anti-thymocyte globulin), which treats transplant rejection in kidney transplant patients. The recall was initiated on Aug. 2 when one lot of the drug failed a periodic stability test, a study to check the shelf life of a drug within specified conditions. "Genzyme has not identified any new safety risk to patients who have received Thymoglobulin from the implicated lot numbers, and there are no confirmed safety issues directly associated with the stability failure," the FDA said in a recall notice on its website. The raw material used to produce Thymoglobulin was considered the cause of change in the shelf life of the drug. Additional lots, manufactured with comparable quality of the raw material, are also being recalled due to the potential risk of a stability failure.

By Ronnie Cohen SAN FRANCISCO (Reuters) Aug 28 - Yosemite National Park is warning 1,700 people that they may have been exposed to the potentially deadly rodent-borne lung disease known as hantavirus while staying in the famous California park and said that two visitors had died from the illness. The tourists who died had stayed in Curry Village, a popular camping area tucked below the park's sheer granite walls, a Yosemite spokesman said on Tuesday. A third visitor was sickened by the virus but recovering. Investigators were looking into whether a fourth visitor was suffering from the illness, which is carried by wild rodents. All four stayed in the area's tent cabins on overlapping days in mid-June, spokesman Scott Gediman said. "We are encouraging anyone who stayed in Curry Village since June to be aware of the symptoms of hantavirus and seek medical attention at the first sign of illness," the park's superintendent, Don Neubacher, said in a statemen

August 29, 2012 — The use of adjuvant chemotherapy in patients with stage II colon cancer remains controversial because many of these patients have a very favorable prognosis after surgery. Even when the decision to use chemotherapy is made, the choice of which drugs to use is a matter of debate. Oxaliplatin ( Eloxatin , sanofi-aventis) has become popular in recent years as part of FOLFOX, the triple-drug chemotherapy regimen of infusional fluorouracil, leucovorin, and oxaliplatin. Oxaliplatin was added to this regimen after early data from a pair of large randomized trials showed significant improvement in disease-free-survival. However, as the data from these trials have matured, the hoped-for improvement in overall survival has not materialized. In fact, a new analysis of subgroups from one of these trials has confirmed that adding oxaliplatin does not improve overall survival. The analysis,  published online  August 20 in the  Journal of Clinical Oncology , was conducted

August 29, 2012 — The US Food and Drug Administration (FDA) announced approval today of a new pediatric dosage form of everolimus for use in very young children with a rare brain tumor. The new formulation, everolimus tablets for oral suspension ( Afinitor Disperz , Novartis), is the first approved pediatric-specific dosage form developed for pediatric tumors, the FDA notes. This new dosage formulation is able to dissolve more rapidly and provides for smaller dose increments, thus allowing for greater dosing flexibility. The product is indicated for use in the treatment of subependymal giant cell astrocytoma (SEGA). Everolimus was granted an  accelerated approval in 2010  to treat SEGA in patients with tuberous sclerosis complex. The new formulation is recommended for patients aged 1 year or older with tuberous sclerosis complex who are diagnosed with inoperable SEGA. Before the approval of this new formulation, everolimus was not recommended for use in children younger than

August 29, 2012 — The US Food and Drug Administration (FDA) has approved tbo-filgrastim (Sicor Biotech/Teva Pharmaceuticals) for the treatment of severe neutropenia associated with use of chemotherapy in nonmyeloid malignancies. Filgrastim is a granulocyte colony-stimulating factor (G-CSF) analog used to stimulate the proliferation and differentiation of granulocytes. Two forms of filgrastim are already available in the US — one injected daily ( Neupogen , Amgen) and a pegylated form injected once per chemotherapy cycle ( Neulasta , Amgen); another version of filgrastim ( Tevagrastim , Teva) has been marketed outside of the US. Teva notes that Tevagrastim and Neupogen are biosimilar, and that the Neupogen patent will expire in the US next year. The company also notes that that tbo-filgrastim is a short-acting recombinant form of G-CSF, and that it is the first new G-CSF to be approved in the US in more than 10 years. Teva reports that it will start marketing tbo-filgrastim possibl

August 29, 2012  (Munich, Germany)  — Results from the STEMI cohort of the  ATLAS ACS 2 TIMI 51  trial have shown similar findings to the overall ACS population, with the 2.5-mg twice-daily dose of  rivaroxaban  (Xarelto, Bayer/Johnson & Johnson) showing better results than the 5-mg twice-daily dose. Presenting the data at the  European Society of Cardiology (ESC) 2012 Congress ,  Dr Jessica Mega  (Brigham and Women's Hospital, Boston, US) noted that long-term anticoagulant therapy has been of particular interest in the STEMI population, and these patients were a prespecified subgroup in the ATLAS-2 TIMI51 study. While the 2.5-mg dose of rivaroxaban did show an encouraging reduction in cardiac events in this population, the discussant of the STEMI analysis at the ESC meeting,  Dr Andreas Zeiher  (University of Frankfurt, Germany), suggested that there may be a relatively limited place for the drug in this indication at present. Rivaroxaban is awaiting approval for the

August 29, 2012  (Munich, Germany)  — A new prespecified analysis of the  ARISTOTLE   study has shown that the new oral anticoagulant  apixaban  (Eliquis, Bristol-Myers Squibb/Pfizer) was better than  warfarin  at preventing the primary outcome, stroke or systemic embolism, in atrial-fibrillation patients, regardless of renal function [1]. And patients with kidney disease seemed to have the greatest reduction in major bleeding with apixaban. These findings are important, because patients with renal insufficiency pose a problem for any kind of anticoagulant treatment due to their increased risk for both thromboembolic and bleeding events. Up to 20% of those with AF have some renal dysfunction, making treatment decisions difficult in this patient group. These new results suggest that "apixaban may be particularly suited to address the unmet need for more effective and safer stroke prevention in patients with AF and renal dysfunction," say  Dr Stefan H Höhnloser  (JW Goet