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  • WASHINGTON— One of the nation's leading medical researchers joined the Food and Drug Administration on Monday, taking on the agency's No. 2 leadership job at a critical juncture for prescription drugs, medical devices and tobacco products. Robert Califf comes to the job of FDA deputy commissioner after more than 30 years as a researcher and administrator at...

  • March 2- The U.S. Food and Drug Administration rejected Pacira Pharmaceuticals Inc's application for expanding the use of its post-surgery pain drug, Exparel. Pacira said on Monday it would work with the FDA to secure the new indication for Exparel, which will allow it to harness a wider range of post-operative patients. Exparel, approved in April 2012 for...

  • March 2- The U.S. Food and Drug Administration rejected Pacira Pharmaceuticals Inc's application for expanding the use of its pain drug, exparel.

  • The scopes were linked to the exposure of 179 patients to drug-resistant bacteria at UCLA's Ronald Reagan Medical Center in Los Angeles and may have contributed to two deaths. In early 2014, following a superbug outbreak at a hospital in Illinois, the FDA asked Fujifilm Holdings Corp, Olympus Corp and Pentax, which make the devices, to submit their test results...

  • Dublin- based Actavis Plc holds the commercial license for the product, but the marketing application was submitted by non-profit pharmaceutical company Medicines360, which holds the U.S. public sector clinic rights. The companies expect the device, which also helps to check heavy menstrual bleeding, to be available in the United States by the second quarter...

  • Actavis Plc holds the commercial license to the device, Liletta. Actavis and Medicines360 expect the device to be available for use in the United States by the second quarter of 2015.. The Actavis device will compete in the $1 billion global market for UIDs, said Michael WaterHouse, an analyst at brokerage Morningstar.

  • Actavis' contraceptive device wins U.S. FDA approval Friday, 27 Feb 2015 | 8:10 AM ET

    Feb 27- The U.S. Food and Drug Administration said on Friday it approved a hormonal contraceptive device, providing American women another reversible contraceptive choice as effective as sterilization. Actavis Plc holds the commercial license to the device, the marketing application of which was submitted by non-profit pharmaceutical company...

  • Feb 25- The U.S. Food and Drug Administration on Wednesday approved the use of Actavis Plc's antibiotic, Avycaz, to battle drug-resistant bacteria known as superbugs. Although a number of companies including Roche Holdings AG, Tetraphase Pharmaceuticals Inc, Achaogen Inc and Cempra Inc, are developing drugs for a variety of superbugs, Gabelli& Co analyst Kevin...

  • Feb 26- Diagnostics company Corgenix Medical Corp said on Thursday U.S. health regulators had approved its rapid Ebola test for emergency use, in response to the world's worst outbreak of the virus that killed more than 10,000 so far. The company's ReEBOV Antigen Rapid Test, which involves putting a drop of blood on a paper strip and waiting for at least 15 minutes...

  • FDA approves Corgenix's Ebola test for emergency use Thursday, 26 Feb 2015 | 9:34 AM ET

    Feb 26- Corgenix Medical Corp said on Thursday the U.S. Food and Drug Administration approved its Ebola test for emergency use. The company's so-called ReEBOV Antigen Rapid Test involves putting a drop of blood on a small paper strip and waiting for 15-25 minutes for a reaction. The test is able to correctly identify about 92 percent of Ebola-infected patients...

  • UPDATE 1-Actavis' superbug antibiotic gets U.S. approval Wednesday, 25 Feb 2015 | 7:50 PM ET

    Feb 25- The U.S. Food and Drug Administration on Wednesday approved the use of Actavis Plc's antibiotic, Avycaz, to battle drug-resistant bacteria known as superbugs. Although a number of companies including Roche Holdings AG, Tetraphase Pharmaceuticals Inc, Achaogen Inc and Cempra Inc, are developing drugs for a variety of superbugs, Gabelli& Co analyst Kevin...

  • FDA approves new antibiotic combo from Actavis Wednesday, 25 Feb 2015 | 6:02 PM ET

    The drug from Actavis PLC contains two ingredients, cephalosporin and avibactam, designed to help fight antibiotic-resistant bacteria. The Food and Drug Administration approved Avycaz to treat certain abdominal infections, in combination with another drug, and for complicated urinary-tract infections, including kidney infections, for which there are...

  • Actavis' superbug antibiotic gets U.S. approval Wednesday, 25 Feb 2015 | 5:28 PM ET

    Feb 25- The U. S Food and Drug Administration approved on Wednesday Actavis Plc's antibiotic to treat two infections caused by drug-resistant bacteria, or superbugs. The decision comes after a panel advising the agency recommended approval of the drug, Avycaz, in December. The drug, used in combination with generic antibiotic metronidazole, aims to treat adults...

  • Feb 25- Antares Pharma Inc said its once-weekly testosterone injection met the main goal in an ongoing late-stage study in testosterone-deficient adult males. The U.S. Food and Drug Administration asked Antares last month for additional safety data on the drug, to be sold as QuickShot Testosterone, after a patient developed hives in a separate mid-stage...

  • Pet owner Frank Lucido filed the suit on Feb. 5 in U.S. District Court in the Northern District of California against Nestle Purina PetCare Company. Purina issued a statement saying "there are no quality issues with Beneful," and dog owners could continue feeding it to their dogs without any concern. The Food and Drug Administration has approved the use of...

  • Last week the FDA warned that the complex design of the reusable duodenoscopes, which are threaded through the mouth, throat and stomach and used in a variety of gastrointestinal procedures, makes them difficult to disinfect properly, even when instructions provided by the manufacturers are followed. The urgency comes as the FDA faces some criticism for...

  • Watchdog group seeks FDA ban of antifungal tablets Tuesday, 24 Feb 2015 | 10:08 AM ET

    Public Citizen filed a petition Tuesday asking the FDA to ban ketoconazole tablets, which are used against hard-to-treat fungal infections. In July 2013 the FDA restricted ketoconazole's use to infections that do not respond to other drugs. Those findings were delivered at an agency workshop in January 2013, six months before the FDA decided to restrict the...

  • Feb 23- The U.S. Food and Drug Administration on Monday approved Novartis AG's drug to treat patients who have relapsed after earlier therapies for multiple myeloma, an aggressive blood cancer, even though an advisory panel in November recommended against approval. Farydak was approved for use in combination with Takeda Pharmaceutical Co Ltd's Velcade and...

  • FDA approves Novartis drug for bone marrow cancer Monday, 23 Feb 2015 | 3:58 PM ET

    WASHINGTON— Federal health officials have approved a new drug from Swiss drugmaker Novartis to treat a form of bone marrow cancer. The Food and Drug Administration said Monday it approved Farydak for patients with multiple myeloma, which causes the buildup of plasma cells in the bone marrow. However, after the meeting Novartis submitted additional...

  • Novartis' blood cancer drug wins U.S. approval Monday, 23 Feb 2015 | 3:18 PM ET

    Feb 23- The U.S. Food and Drug Administration approved Novartis AG's drug for treating a form of cancer that affects white blood cells. Multiple myeloma causes these cells to rapidly multiply and crowd out healthy blood cells from the bone marrow. The drug, Farydak, slows the multiplication of cells or causes them to die by blocking the activity of certain enzymes...