Buy this domain.

free-best-hosting.com

Celgene Cancer Drug Review Extended by the FDA | 24-7-news.com cialis online

Celgene Cancer Drug Review Extended by the FDA

AddThis Social Bookmark Button

The Food and Drug Administration (FDA) has decided to extend its review of the cancer-fighting drug Revlimid, according to the drug’s developer, Celgene Corporation.

The FDA was expected to approve Revlimid this week for the treatment of a blood condition called myelodysplastic syndromes, or MDS.  The federal agency announced its three-month delay to the company on Friday, September 30.

The review’s extension is a result of the FDA requiring more time to review additional information on Celgene’s RevAssist risk-management program.  According to the company, the RevAssist program includes physician education, as well as interim pregnancy testing before and during treatment.

According to Reuters, Revlimid is a derivative of thalidomide, a drug associated with birth defects, and the delay in approval for Revlimid is designed to satisfy the FDA that a fetus would not be exposed to the drug.

The news agency reported that Celgene had already submitted animal studies that showed Revlimid’s structure and biology were different from thalidomide and did not cause birth defects in rats and rabbits.  Celgene’s spokesman, Brian Gill, said that until the FDA is 100% sure, it wants additional animal studies to confirm that the drug is significantly different from thalidomide.

Celgene has been marketing thalidomide under the product name Thalomid since 1998 for the treatment of consequences related to leprosy.  However, according to Reuters, many physicians use it on an “off-label” basis to treat another blood cancer called multiple myeloma, although it is not officially approved to treat that condition.

Thalomid has rigorous restrictions on its use, including frequent pregnancy testing of female patients, to protect fetuses from exposure.  Celgene said that they are discussing a similar program for Revlimid with the FDA.

« »

Comments are closed.

NEWS CATEGORIES

GOVERNMENT NOTICES

ARCHIVES


Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!
defective-hip-replacement.com

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!
CAT-Scans-Radiation-Exposure.com

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.
WaterContaminationFrom Fracking.com

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to PCBs.com

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!
TallisPhoto.com

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Poligrip-Lawsuit.com

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!
Nassau-Personal-Injury-Lawyer-Online.com

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!
nursing-home-blog.com

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!
www.nassau-car-accident-lawyer-online.com

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!
www.suffolk-car-accident-lawyer-online.com

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!
www.veterans-benefits-denial.com

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!
www.oil-rig-spills.com

Whistle Blower

Stand up and say what you think is right. See something, say something.
whistlebloweradvisor.com