FDA News

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).
 

Boston Scientific, Bladder Health Network Enter Pact

Jody A. Charnow May 21, 2010

Boston Scientific Corp., of Natick, Mass., has entered into a four-year exclusive marketing agreement with Bladder Health Network (BHN), a privately held company headquartered in Jackson, Miss., that offers advanced testing solutions for urinary incontinence.
 

New Formulation of PAH Medication Is Now Available

Jody A. Charnow May 21, 2010

Epoprostenol for Injection, an improved formulation of epoprostenol that is stable at room temperature, is now commercially available, according to the drug's maker, Actelion Pharmaceuticals US, Inc., of South San Francisco, Calif.
 

Data Support PCa Vaccine's Mechanism of Action

Jody A. Charnow May 21, 2010

Phase 3 trial data presented at the American Association of Cancer Research annual meeting support the mechanism of action of Provenge (sipuleucel-T), a novel investigative immunotherapy for advanced prostate cancer, according to a statement issued by Dendreon Corp., of Seattle, which is developing the treatment.
 

Buccal Tablets for Oropharyngeal Candidiasis Cleared

Jody A. Charnow May 21, 2010

The FDA has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis in adults and childen aged 16 years and older.
 

High-Resolution Camera for Medical Imaging Approved

Jody A. Charnow May 21, 2010

Toronto-based hybridyne Imaging Technologies has received FDA clearance for ProxiScan, a high-resolution gamma camera for detecting cancer and other abnormalities.
 
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