Just Approved and Launched

justapproved
  • In January 2012, Astellas Pharma Inc. and XenoPort, Inc. received marketing approval in Japan for Regnite® (gabapentin enacarbil) for the treatment of moderate-to-severe primary restless legs syndrome (RLS). Regnite® has a different mechanism of action than other RLS treatments currently available in Japan. Regnite® is dosed once daily. It has been shown in clinical studies to improve International Restless Legs Syndrome Rating Scale scores compared to placebo.
  • On January 23, 2012, Alere Inc, announced FDA approval of its Influenza A&B Test for use in the United States. The Alere™ Influenza A&B Test is intended for use in the physician's office. It uses highly sensitive antibodies to detect influenza types A and B antigen. Sample collection for the test is performed with a nasal swab. Results are provided in 10 minutes, making it possible for physicians to administer treatment while patients are still in the office.
  • Also in January, the FDA granted 510k clearance to Riverain Technologies’ Temporal Comparison software, which is designed to electronically compare current and prior chest X-ray images and help identify nodules that may be early-stage lung cancer. The software aligns and registers the two images to produce a third, subtraction image, which allows radiologists to pinpoint subtle changes that show up more clearly than on a traditional X-ray. Temporal Comparison also has received approval for marketing in the European Union.
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