Rockville
FDA: Statins Do Not Increase The Risks Of Lou Gehrig's Disease
Submitted by Carina Rose on Tue, 09/30/2008 - 08:12
The Food and Drug Administration said that an analysis of many studies on cholesterol-lowering drugs known as statins, have not shown any increase of amyotrophic lateral sclerosis, or ALS, a condition also known as Lou Gehrig's disease.
FDA To Review Experimental Anemia Drugs
Submitted by Carina Rose on Sat, 09/27/2008 - 08:19
The US FDA has said that they are reviewing Amgen and Johnson & Johnson’s experimental blockbuster anemia drugs, which have been associated with higher death rates in a study involving stroke patients.
FDA Brings In Panel Of Outside Experts For BPA Risk Assessment
Submitted by Carina Rose on Thu, 09/18/2008 - 05:44Amid the government’s mixed messages with regard to ‘Bisphenol A’ (BPA), the Food and Drug Administration has reopened the debate over this chemical used in many plastic products, including baby bottles. Reiterating their earlier view, government toxicologists at the U.S. National Institutes of Health asserted that BPA presents ‘some concern’ with regard to harmful effects on development of the prostate and brain, and for behavioral changes in fetuses, infants and children.
FDA Okays ProStrakan’s ‘Anti-Nausea Patch’ For Chemo Patients
Submitted by Carina Rose on Thu, 09/18/2008 - 04:36
The Food and Drug Administration has given its approval to the first ‘anti-nausea patch’ for chemotherapy patients. The patch, called Sancuso, will provide relief to cancer patients for up to five days.
The patch will be required to be worn on the arm, and through the skin, it will deliver a widely used anti-nausea medicine called ‘granisetron’. It has been developed by the Scottish company, ProStrakan, and will available by the end of the year.
FDA Bans Generic Drugs From Indian Company Ranbaxy
Submitted by Carina Rose on Wed, 09/17/2008 - 08:14
The U.S Food and Drug Administration has denied entry to more than 30 generic drugs made by India’s Ranbaxy Laboratories into the United States, citing poor quality. The FDA’s Import Alert blocks the import of generic drugs, which include the cholesterol-lowering drugs simvastatin and pravastatin, the antibiotic clarithromycin, the HIV drugs lamivudine and zidovudine, as well as the diabetes drug metformin.
FDA Puts Rituxan Under Scanner
Submitted by Carina Rose on Mon, 09/15/2008 - 08:04
Rituxan, Arthritis and cancer drug by Genentech, Inc. as well as by Biogen Idec, Inc. is under scanner. The Food and Drug Administration (FDA) reported a case of a deadly brain infection’ progressive multifocal leukoencephalopathy (PML) in a patient who was prescribed the drug.
Rituxan, known generically as rituximab was approved to treat non-Hodgkin’s lymphoma in 1997 and rheumatoid arthritis in 2006.
Merck Vaccine Gardasil Offers Protection Against Vaginal Cancer
Submitted by Carina Rose on Mon, 09/15/2008 - 07:29
FDA has approved Merck and Co’s Gardasil, as a protection against rare vaginal and vulva cancer in young women between the age group of 9 – 26. The vaccine is already available in the US as prevention from cervical and genital warts in girls and women of same age group.
FDA Considers Giving Approval To Pfizer’s Fablyn For Osteoporosis Treatment
Submitted by Carina Rose on Wed, 09/10/2008 - 09:51
FDA panel is considering giving approval to Pfizer’s Fablyn (lasofoxifene tartrate) for the treatment of osteoporosis. The panel feels that the drug benefits overweight, but it has also advised that the drug administration should be limited to women at high risk fracture or those who do not respond to other treatments.
Panel members gave a green signal on the premise that other alternative treatments to osteoporosis also have multiple side effects. The drug would be most beneficial to post menopausal women.
