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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
Jody A. Charnow
July 27, 2010
Hisamitu 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
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.
Company Introduces Its Novel Male Sling for SUI
Jody A. Charnow
June 14, 2010
San Francisco-based Coloplast has announced the debut of a new sling for treating male stress urinary incontinence (SUI).
Lower Dosage Strength Sirolimus Tablets Available
Jody A. Charnow
June 14, 2010
A lower dosage strength sirolimus (Rapamune) tablet is now commercially available, according to the drug's maker, Pfizer Inc., of New York.
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