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  • FDA declines to approve Bydureon

    INDIANAPOLIS The Food and Drug Administration declined to approve a long-anticipated diabetes drug made by Eli Lilly and two other companies, the companies said Tuesday.

    Lilly, Amylin Pharmaceuticals and Alkermes said the FDA issued them a complete response letter for their application for Bydureon (exenatide), a once-weekly version of the Type 2 diabetes drug Byetta. A complete response letter means that the FDA has completed review of a regulatory application, but issues remain that preclude approval.

     

  • Cardiovascular, diabetes risk associated with prostate cancer drug class

    SILVER SPRING, Md. Patients taking a certain class of drugs mostly used for prostate cancer may be at higher risk of heart disease and diabetes, the Food and Drug Administration warned on Wednesday.

     

  • FDA approves BI's Pradaxa

    SILVER SPRING, Md. The Food and Drug Administration approved a drug for preventing strokes and blood clots in patients with abnormal heart rhythm, the agency said Tuesday.

     

    The FDA announced the approval of Pradaxa (dabigatran etexilate) capsules, an anticlotting drug made by Boehringer Ingelheim for patients with atrial fibrillation, a type of abnormal heart rhythm that affects more than 2 million Americans.

     

     

  • Novo Nordisk looks at ways to raise diabetes awareness in new report

    PRINCETON, N.J. Novo Nordisk is underscoring the importance of diabetes screenings with a new report, the Novo Nordisk BlueSheet.

    The third edition of the drug maker's BlueSheet report examined various ways awareness and education play an integral role in the prevention, detection and treatment of diabetes. It also provides an update on the Diabetes Advocacy Alliance, a coalition that is committed to helping improve diabetes prevention, detection and care by aligning key diabetes stakeholders around diabetes-related policy and legislative efforts.

  • Purdue Pharma supports state Rx monitoring programs

    CHARLESTON, S.C. Drug maker Purdue Pharma has donated $200,000 to the National Association of State Controlled Substances Authorities to address the abuse of prescription drugs, NASCSA said Tuesday.

     

    The grant, presented at the group’s annual conference in Charleston, S.C., is designed to support state prescription drug monitoring programs. The NASCSA will be in charge of distributing the money to state agencies. Purdue is the maker of OxyContin (oxycodone), a commonly abused prescription opioid painkiller.

     

     

  • FDA OKs expanded use of Baraclude

    PRINCETON, N.J. The Food and Drug Administration has approved an additional use for a hepatitis drug.

     

    Bristol-Myers Squibb announced Monday the approval of Baraclude (entecavir) as a treatment for chronic hepatitis B in adults with decompensated liver disease. The drug already is approved for adults with evidence of active viral replication.

     

     

  • Fera launches Garamycin

    NEW YORK Fera Pharmaceuticals has launched a preservative-free ointment for treating bacterial infections of the eye, the company said Monday.

     

    Fera said the launch of Garamycin (gentamicin sulfate) was to meet an unmet need for a preservative-free version of the drug. The Food and Drug Administration had received reports of allergic reactions in infants who had received formulations of the drug with preservatives.

     

     

  • Botox approved for migraines

    SILVER SPRING, Md. A popular beauty treatment has won approval as a medical treatment as well.

     

    The Food and Drug Administration announced Friday the approval of Allergan’s Botox (onabotulinumtoxinA) for preventing headaches in adult patients with chronic migraine.

     

     

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