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Sun, 12/05/2010 - 19:22 by Samia Sehgal
An advisory committee for the U.S. Food and Drug Administration (FDA) has given the green signal to expanding the use of the popular Lap Band weight-loss device, by allowing it to be used on people who are less than severely obese. A formal FDA approval may soon follow.
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Tue, 11/02/2010 - 05:16 by harsheeb
Washiington-- The U.S. Food and Drug Administration says it has approved a drug to treat tumors caused by a rare genetic disorder, tuberous sclerosis.
The drug, Afinitor, is intended to treat slow-growing benign tumors TS causes to grow in the brain and in other parts of the body, including the eyes, lungs, liver, heart, skin and kidneys, an FDA release said Monday.
Such tumors, called subependymal giant cell astrocytomas, are considered a major diagnostic feature of TS, seen in 6 percent to 9 percent of patients. The disease can be fatal for patients who develop complications with tumor growth on the brain.
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Fri, 09/10/2010 - 14:38 by Natalie James
The U.S. Food and Drug Administration issued warning letters Thursday to five electronic cigarette distributors, saying that they were violating federal law by claiming their products help smokers kick the habit.
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Tue, 05/25/2010 - 07:54 by harsheeb
Washington -- The U.S. Food and Drug Administration says Ortho-McNeil Pharmaceutical LLC has been fined $6.14 million under the U.S. Food, Drug & Cosmetic Act.
Friday's guilty plea and sentencing in Boston U.S. District Court was for illegally marketing the company's epilepsy drug Topamax for unapproved uses, the FDA said.
The government said Ortho-McNeil promoted Topamax for psychiatric uses, but the FDA never approved the drug to treat any psychiatric disorders.
An affiliate of Ortho-McNeil called Ortho-McNeil-Janssen Pharmaceuticals Inc.
will pay $75.3 million to resolve related civil allegations under the False Claims Act.
Orth-McNeil is a division of Johnson & Johnson Inc.
Copyright 2010 United Press International
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Sat, 05/15/2010 - 15:46 by Natalie James
Ingesting over-the-counter Benadryl Extra Strength Itch Stopping Gel can cause serious health problems, including unconsciousness, hallucinations, and confusion, the U.S. Food and Drug Administration warned Wednesday.
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Fri, 05/07/2010 - 11:26 by harsheeb
The U.S. Food and Drug Administration
Washington -- The U.S. Food and Drug Administration announced approval Thursday of Natazia, a combination hormonal tablet for use as an oral contraceptive.
Officials said Natazia contains two female hormones -- an estrogen (estradiol valerate) and a progestin (dienogest) -- and is the first four-phasic oral contraceptive marketed in the United States. The FDA said "four-phasic" refers to the doses of progestin and estrogen varying at four times throughout each 28-day treatment cycle.
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Wed, 05/05/2010 - 09:05 by harsheeb
Washington -- The U.S. Food and Drug Administration says it is going to require a printed medication guide be given to patients using Vivitrol injectable suspension.
The FDA said it will require a medication guide detailing the risk of injection site reactions, as well as other information, be given to Vivitrol patients.
Officials said Vivitrol (naltrexone ) is an extended release, injectable suspension indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting.
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Tue, 04/27/2010 - 09:05 by harsheeb
Washington -- The U.S. Food and Drug Administration says it is changing the way its expert panels review and discuss data and information during public hearings.
In the past, panel discussions have not always reflected a panel's final vote on approval, the FDA said. Now, instead of voting to approve a premarket application, the panels will vote on the safety and effectiveness of a device and the device's risk versus its benefit.
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Thu, 04/01/2010 - 07:11 by harsheeb
Washington -- The U.S. Food and Drug Administration says it is implementing a rule requiring medical device makers provide information pertaining to pediatric patients.
The FDA said such manufactures must supply information in certain pre-market applications on pediatric patients who suffer from a disease or condition that the device is intended to treat, diagnose or cure, even if the device is intended for adult use.
"Very few devices are developed or assessed specifically for use in pediatric patients -- those 21 or younger at the time of treatment or diagnosis," the FDA said in a statement. "This effort will provide a better understanding of which devices developed for use in adults should be assessed or modified for use in pediatric populations."
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Wed, 03/17/2010 - 08:02 by harsheeb
Washington -- The U.S. Food and Drug Administration Tuesday ordered Glenmark Generics and Konec Inc. to stop marketing unapproved nitroglycerin tablets.
Nitroglycerin tablets are placed under the tongue to relieve chest pain or to stop a heart attack. But the tablets manufactured by the two companies have not been proven safe and effective, the FDA said, and the products' labeling has not been reviewed.
The agency's warning letters require Glenmark, a Mahwah, N.J., company and Konec, located in Tucson, Ariz., to remove the unapproved tablets as part of the FDA's Unapproved Drugs Initiative. The initiative was announced in 2006 to address marketed drugs that had not received FDA approval.
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Wed, 03/10/2010 - 09:28 by harsheeb
Washington -- The U.S. Food and Drug Administration says it has approved Botox to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults.
Spasticity is common after stroke, traumatic brain injury or the progression of multiple sclerosis.
"Muscles affected by spasticity have increased stiffness and tightness, which may lead to pain, difficulties with hygiene and other activities of daily living, and may affect how a patient looks," said Dr. Russell Katz, director of the FDA's Division of Neurology Products. "In clinical trials, treatment with Botox was found to be beneficial to patients with upper limb spasticity."
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Thu, 03/04/2010 - 17:52 by Natalie James
The U.S. Food and Drug Administration has issued warning for food manufacturers who are making false and misleading statements about nutrition and health benefits on their product packaging.
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