FDA News

Toan Le, 51, and Hang Ho, 41, a married couple residing in Burien, Washington, pleaded guilty today in U.S. District Court in Seattle in connection with their attempt to import and use a cosmetic device that had not been approved for use in the U.S. by the Food and Drug Administration.

The U.S. Food and Drug Administration has approved the use of the CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.

Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device.

Ming Yan, who operates a computer store in North Providence, has pleaded guilty to causing the misbranding of the prescription drug sildenafil citrate, which is marketed as Viagara, and to copyright infringement. Immigration and FDA agents seized counterfeit sildenafil citrate pills and more than 1,000 pirated movie DVDs from Yan’s store and home in March 2008.

Demerol Diverted at Bellevue Surgery Clinic
DREA LYNNE GIBSON, 43, of Fall City, Washington, was sentenced today in U.S. District Court in Seattle to a year and a day in prison and three years of supervised release for product tampering in violation of federal law.

14 events reported in which a 200 J biphasic defibrillator was ineffective in providing fibrillation / cardioversion therapy to a patient.

Dr. Margaret Hamburg, Commissioner of Food and Drugs, today sent a letter to America’s doctors thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on the safety of the 2009 H1N1 vaccines.

Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery.

Cutaneous T-cell lymphoma affects about 1,500 Americans annually

The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).

Product containers may contain particulate matter that could act as emboli and lead to impeded blood flow.