Regulatory and Drug Approvals News

Regulatory Affairs and Drug Approvals News

InSite Vision Receives Regulatory Approval For AzaSite(R) In Canada

InSite Vision Incorporated (AMEX:ISV) announced that the Therapeutic Products Directorate (TPD) of Health Canada has approved the company's new drug submission (NDS) for AzaSite (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis (pink eye) in adults and children one year and older.

Cardima Receives CE Mark Approval For Its Surgical Ablation Probe With Stabilization Sheath

Cardima, Inc. (OTCBB: CADM), a medical device company focused on the treatment of atrial fibrillation (AF) and manufacturer of the Cardima Surgical Ablation System, today announced that it has received CE Mark approval for its Surgical Ablation Probe with Stabilization Sheath.

FDA Advisory Committee Unanimously Recommends Accelerated Approval Of Avastin For Previously Treated Brain Cancer (Glioblastoma)

Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously that the response seen with Avastin® (bevacizumab) in people with previously treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit.

Burgess Bill Requiring More Transparency In Health Insurance Plans Passes House, USA

Bipartisan legislation requiring more transparency and up-front information on health insurance plans, introduced by Congressman Michael Burgess, M.D. (R-Texas), passed the House of Representatives today.

Trust For America's Health On The Recall Of Certain Pistachios And The U.S. Food Safety System

The following is a statement from Jeff Levi, PhD, Executive Director of Trust for America's Health (TFAH): Today's recall of pistachios is the latest reminder of how vulnerable our food safety system is. Our current food safety system is not adequately set up to respond to many modern threats to our food, including Salmonella.

Need For Pediatric Cardiac Devices Exposed By Study

Nearly two-thirds of children who undergo routine interventional cardiology procedures -- those involving a catheter to treat structural disorders of the heart -- may be receiving treatment with a device that's being used for an off-label application.

Medtronic Receives Regulatory Approval For Endeavor(R) Drug‐Eluting Coronary Stent In Japan

Medtronic, Inc. (NYSE: MDT), announced approval of its Endeavor drug‐eluting coronary stent system by the Japanese Ministry of Health, Labor and Welfare (MHLW), clearing the way for the highly anticipated launch of the product in the world's second largest market for advanced medical technology.

Afinitor(R) Approved In US As First Treatment For Patients With Advanced Kidney Cancer After Failure Of Either Sunitinib Or Sorafenib

Novartis announced that Afinitor® (everolimus) tablets has been approved by the US Food and Drug Administration (FDA) for patients with advanced renal cell carcinoma (RCC) after failure of treatment with Sutent® (sunitinib)* or Nexavar® (sorafenib)**.

Editorial, Opinion Piece Respond To Federal Judge's Ruling On Nonprescription Access To Plan B

The following summarizes an opinion piece and editorial responding to a federal judge's order last week for FDA to reconsider age restrictions on nonprescription sales of the emergency contraceptive Plan B. ~ Marie Cocco, Indianapolis Star: U.S.

Gore Receives FDA Approval For Larger Diameter, Small Profile AAA Endoprosthesis

W. L. Gore & Associates (Gore) announced that it has received approval from the US Food and Drug Administration (FDA) to market a 31 mm diameter version of the GORE EXCLUDER® AAA Endoprosthesis. The device provides physicians with a safe and effective endovascular option to treat abdominal aortic aneurysms (AAA) in patients with aortic inner neck diameters up to 29 mm.

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