FDA Information - November 20, 2008

Ulcerative Colitis Treatment Approved By FDA

September 18, 2005 - Topics fda, ulcer, research, food and surgery
The Food and Drug Administration (FDA) approves a new biologic treatment to treat ulcerative colitis. Manufacturer Centocor, Inc. announces that Remicade has received the green light to treat the chronic inflammatory bowel disease.

Remicade's efficiency in the treatment of inflammatory bowel disease is well established. It was first approved in the United States for the treatment of Crohn's disease in 1998.Remicade remains to this day the only anti-tumor necrosis factor therapy indicated for the treatment of Chron's. With this new approval for the treatment of ulcerative colitis, Remicade is now the only biologic indicated for the treatment of both types of inflammatory bowel diseases

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FDA Approves Ulcerative Colitis Treatment

September 18, 2005 - Topics fda, ulcer, research, food and surgery
The Food and Drug Administration (FDA) approves a new biologic treatment to treat ulcerative colitis. Manufacturer Centocor, Inc. announces that Remicade has received the green light to treat the chronic inflammatory bowel disease.

Remicade's efficiency in the treatment of inflammatory bowel disease is well established. It was first approved in the United States for the treatment of Crohn's disease in 1998.Remicade remains to this day the only anti-tumor necrosis factor therapy indicated for the treatment of Chron's. With this new approval for the treatment of ulcerative colitis, Remicade is now the only biologic indicated for the treatment of both types of inflammatory bowel diseases

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FDA Panel Opposes Prostate Cancer Drug

September 14, 2005 - Topics fda, prostate cancer, cancer, men and safety
A Food and Drug Administration advisory committee on Tuesday declined to recommend a drug intended to treat prostate cancer, after a report questioned its safety and effectiveness.

Abbott Laboratories presented Atrasentan, shelved under the name Xinlay, as a treatment for men with an advanced stage of prostate cancer that spreads to the bone. The FDA's Oncologic Drugs Advisory Committee, however, voted unanimously against its recommendation

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FDA Delayed Safety Alert On Guidant Heart Devices

September 13, 2005 - Topics safety, fda, pharmaceutical and food
The Food and Drug Administration did not issue a safety alert about Guidant's heart devices until five months after it was warned about problems with the product, according to a New York Times article Monday.

As early as February, the FDA received data showing the Indianapolis-based company's defibrillator product, the Ventak Prizm 2 DR, was short-circuiting. However, the FDA did not announce a recall of the device until July 1

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FDA Wants To Allow Inhaled Insulin Treatment

September 11, 2005 - Topics fda, insulin, medicine, safety and food
Diabetics across the nation can be heard cheering Sunday as the Food and Drug Administration passes an inhaled Insulin treatment, an alternative to the daily shot routine that millions have to do on a daily basis.

The panel voted by seven to two to recommend approving the product, called Exubera, on the grounds that its advantages in terms of ease of administration and its potential to improve patient compliance outweighed lingering doubts about its safety

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