Renal & Urology News: World Review for Urologists & Nephrologists

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FDA News Articles

Ultra-Fine Pen Needle for Diabetics Debuts

Jody A. Charnow July 27, 2010

Becton, Dickinson and Company (BD), based in Franklin Lakes, N.J., has launched the BD Ultrafine Nano, which the company says is the world's smallest pen needle.

Over the Counter Pain Relief Patches Introduced

Hisamitsu Pharmaceutical, which has U.S. headquarters in Torrance, Calif., has introduced two over-the-counter pain relief patches to the American market, the Salonpas Pain Relief Patch and Salonpas Arthritis Pain patch.

Marketing Clearance Granted to New Glucose Test Strips

Jody A. Charnow July 27, 2010

Abbott has received FDA clearance to market FreeStyle Lite glucose test strips. The test strips minimize interference during blood glucose testing and are designed to offer a better experience, Abbott says.

Imaging Agent for Bladder Cancer Okayed

Jody A. Charnow July 27, 2010

The FDA has approved Cysview (hexaminolevulinate HCl), an optical imaging agent indicated for use in the cystoscopic detection of non-muscle-invasive papillary bladder cancer in patients suspected or known to have lesions on the basis of prior cystoscopy.

FDA Mulls Application for Prostate Imaging Device

Jody A. Charnow July 27, 2010

ProUroCare Medical, Inc., of Minneapolis, Minn., has filed a de novo application with the FDA seeking marketing clearance for its prostate mechanical imaging (PMI) device (ProUroScan).

Intranasal Ketorolac Cleared for Pain Management

Jody A. Charnow June 14, 2010

A novel prescription intranasal formulation of ketorolac tromehtamine (Sprix Nasal Spray), a non-steroidal anti-inflammatory drug, has been approved for the short-term management of acute moderate to moderately severe pain that requires analgesia at the opioid level.

GnRH Agonist Safety Is Under Review

Jody A. Charnow June 14, 2010

The FDA is conducting a safety review of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs used primarily as a treatment for prostate cancer.

Home Hemodialysis Safety Device Approved

Jody A. Charnow June 14, 2010

The Redsense safety device, which is designed to detect venous needle displacement during hemodialysis (HD), has received FDA approval for home/self use during home HD, according to the device's manufacturer, Redsense Medical.