Tuesday, May 13, 2008

the Food and Drug Administration

Medtronic gets FDA approval for new defibrillators
AP via Yahoo! Finance Tue, 13 May 2008 6:40 AM PDT
Medical device maker Medtronic Inc. said Tuesday the Food and Drug Administration approved a new line of wireless cardiac defibrillators.

Novo Nordisk gets FDA approval for hemophilia drug
AP via Yahoo! Finance Tue, 13 May 2008 6:05 AM PDT
Drug developer Novo Nordisk said Tuesday the Food and Drug Administration approved its new hemophilia treatment NovoSeven RT.

FDA Approves First Generic Ropinirole
Kansas City InfoZine Tue, 13 May 2008 6:53 AM PDT
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

Drug Promises to Restore Sensation After Dental Visit
NYTimes.com via Yahoo! Finance Mon, 12 May 2008 7:36 PM PDT
A small drug company said it won approval Friday from the Food and Drug Administration to market the first drug meant to undo the effects of local dental anesthesia.

Novo Nordisk gets FDA approval for hemophilia drug
INO News Tue, 13 May 2008 6:21 AM PDT
(AP:NEW YORK) Drug developer Novo Nordisk said Tuesday the Food and Drug Administration approved its new hemophilia treatment NovoSeven RT. The Denmark-based company said the product is a room-temperature stable drug used to treat bleeding episodes in hemophilia patients.

Novalar Receives FDA Approval For OraVerse
PharmaceuticalOnline Tue, 13 May 2008 6:16 AM PDT
Novalar Pharmaceuticals, Inc., a dental specialty pharmaceutical company, announced recently that the United States Food and Drug Administration (FDA) has granted marketing approval for OraVerse(phentolamine mesylate).

TechMARK movers: Ardana falls on trial result
ShareCast via Yahoo! UK & Ireland Finance Tue, 13 May 2008 6:59 AM PDT
LONDON (ShareCast) - Drug developer Ardana fell back on a disappointing trial result for its new testosterone cream, which is now unlikely to meet the expected target for patients to get approval from the US Food and Drug Administration.

FDA Approves Covidien System With RFID To Reduce Life-Threatening Errors
DataCollectionOnline Tue, 13 May 2008 4:27 AM PDT
Covidien (NYSE: COV, BSX: COV) recently announced that the U.S. Food and Drug Administration (FDA) has approved Covidien Imaging Solutions' contrast delivery system with radio-frequency identification (RFID) technology. The components integrate novel RFID technology to create a system that is designed to enhance patient safety by reducing the risk of medical errors in radiology departments.

FDA reform proposals spark more debate
Just Food Tue, 13 May 2008 7:04 AM PDT
In the wake of numerous food contamination scares, the effectiveness of the Food and Drug Administration in protecting food safety in the US has been a much discussed subject over the past couple of years. Last month, proposals for extensive reform were put forward by the House Energy and Commerce Committee. Ben Cooper assesses how they have been received by industry representatives, consumer ...

St. Jude gets FDA approval for device database
AP via Yahoo! Finance Mon, 12 May 2008 2:01 PM PDT
Medical device maker St. Jude Medical Inc. said Monday the Food and Drug Administration approved its remote monitoring and data management system for implantable heart devices.




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