U.S. Food and Drug Administration
The U.S. Food and Drug Administration has granted approval to Mylan Technologies, Inc., for the first generic version of Alza Corporation's Duragesic Patch (Fentanyl Transdermal System) used to treat patients suffering from severe chronic pain that cannot be managed with alternative analgesics. When applied to the skin, this patch technology delivers fentanyl, an opioid pain medication that is slowly absorbed into the body through the skin providing pain relief for up to three days (72 hours).
The British Medical Journal has turned over confidential drug company documents that went missing from a 10 year old murder case to the US Food and Drug Administration (FDA) for review. The documents, which were sent to the BMJ by an anonymous source, appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence. They also suggest that Eli Lilly officials were aware in the 1980s that fluoxetine had troubling side effects and sought to minimise their likely negative effect on prescribing.
The U.S. Food and Drug Administration has announced that none of the influenza vaccine manufactured by the Chiron Corporation for the U.S. market is safe for use. This determination is based on FDA's evaluation and inspection of Chiron's influenza vaccine manufacturing plant in Liverpool, England, which concluded this afternoon. The purpose of the FDA inspection was both to evaluate Chiron's investigation, testing and assessment of the defects detected in nine of the one hundred lots of their finished flu vaccine (Fluvirin) manufactured for this year's flu season and also to evaluate their determination that the risk of defects was confined to those specific lots.
The U.S. Food and Drug Administration today issued a Public Health Advisory announcing a multi-pronged strategy to warn the public about the increased risk of suicidal thoughts and behavior (''suicidality'') in children and adolescents being treated with antidepressant medications. The agency is directing manufacturers to add a ''black box'' warning to the health professional labeling of all antidepressant medications to describe this risk and emphasize the need for close monitoring of patients started on these medications.
The U.S. Food and Drug Administration today granted marketing clearance for the first time for the over-the-counter sale of an automatic external defibrillator designed specifically for lay users. The device shocks the heart to restore rhythm in people who are experiencing cardiac arrest. The device, the HeartStart Home Defibrillator manufactured by Philips Medical Systems of Andover, Mass., is already available with a prescription for use at home. Today's clearance means it can now be purchased for home use without a prescription.
The U.S. Food and Drug Administration said it has approved Cymbalta (duloxetine hydrochloride) capsules for the management of pain associated with diabetic peripheral neuropathy. This is the first drug specifically approved for this indication. Cymbalta received a priority review. ''Diabetes affect millions of Americans,'' said Dr. Lester M. Crawford, Acting FDA Commissioner. ''With this new treatment we will hopefully be able to help relieve the pain associated with this terrible disease.'' Diabetic peripheral neuropathy is a problem associated with long standing diabetes or poor glucose control. Peripheral neuropathy is the most common complication of diabetes mellitus, affecting up to 62% of Americans with diabetes.
At present, only two drugs are currently approved for use in the United States for the treatment of alcohol dependence: the opiate antagonist naltrexone and the alcohol-aversive agent disulfiram. A third medication called acamprosate, used in Europe and elsewhere to prevent relapse in alcoholics, is currently under review for use by the U.S. Food and Drug Administration. A new ''proof-of-concept clinical trial'' examines a potential fourth medication -- topiramate -- which can act contemporaneously on more than one neuromodulator of dopamine function. Results indicate that topiramate can reduce consumption and craving in alcohol-dependent patients who are not yet abstinent.
The U.S. Food and Drug Administration has announced the approvals of Epzicom (abacavir/lamivudine) and Truvada (tenofovir disoproxil/emtricitabine), two fixed-dose combination treatments for HIV-1 infection. Control of HIV/AIDS generally requires simultaneous use of three or more drugs from different classes. Combination products bring together different HIV/AIDS drugs in a single medication or co-package and help make treatment regimens less complicated for patients to follow.
After an expedited review, the U.S. Food and Drug Administration has approved an injectable filler to correct facial fat loss in people with HIV infection. The filler, called Sculptra, is the first such treatment approved for a condition known as lipoatrophy, or facial wasting, a sinking of the cheeks, eyes and temples caused by the loss of fat tissue under the skin. Lipoatrophy is common among HIV patients. FDA expedited review of the product because of its importance to people with HIV/AIDS.
For the estimated six to seven million Americans with psoriasis, the warm-weather months of summer might be the most challenging. Instead of being able to cover up their condition with sweaters or pants, psoriasis patients -- forced to keep cool by wearing short-sleeved shirts and shorts -- find themselves revealing the raised, thickened patches of red skin and silvery-white scales that they try so desperately to hide. Now, new treatment advances offer patients more hope in finding a life-long solution to this common skin disease.
The anti-spasticity medication baclofen holds promise for helping cocaine abusers overcome their addiction, a study by a UCLA Neuropsychiatric Institute researcher finds. No medication currently holds U.S. Food and Drug Administration approval for treatment of cocaine addiction. Published in the Dec. 15 edition of the peer-reviewed Journal of Clinical Psychiatry, the randomized, double-blind study found that baclofen used in conjunction with substance abuse counseling significantly reduced cocaine use in recovering addicts compared to placebo coupled with counseling. The study was funded by the National Institute on Drug Abuse as part of a project to screen medications with potential for treating cocaine dependence.
Biotech companies and researchers across the world are focusing on the development of new therapies for the treatment of Non-Hodgkin's Lymphoma (NHL) cancer, a lethal and malignant disease that is spreading at an alarming rate. "About 300,000 people in the United States are affected by NHL and it causes about 23,000 deaths each year in the U.S. alone," says Technical Insights Analyst Al Hester. "This has created a greater need for advanced NHL therapies."
The U.S. Food and Drug Administration has approved Effexor XR for the treatment of patients with social anxiety disorder, a condition which may affect up to 13 percent of Americans at some point in their lives. EFFEXOR XR, already approved for the treatment of depression and generalized anxiety disorder (GAD), is the first available serotonin-norepinephrine reuptake inhibitor (SNRI), and is believed to increase the levels of two key brain chemicals thought to be deficient in individuals suffering from depression and anxiety disorders.
Drug company AstraZeneca said it has submitted an application to the U.S. Food and Drug Administration for approval of quetiapine (Seroquel) as a treatment for acute mania associated with bipolar disorder, or manic-depressive illness. The application follows the completion of a clinical trial programme in bipolar disorder undertaken by the company which reportedly found quetiapine effective as a treatment of acute mania on two levels: as monotherapy (i.e to be prescribed on its own) and as adjunctive therapy with standard mood stabilising medication. These clinical trials have delivered strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm quetiapine to be an ideal first line therapy for the treatment of acute mania associated with bipolar disorder, the company said.
The U.S. Food and Drug Administration has approved the sale of a new wheelchair that enables users to operate on two wheels, allowing them to better negotiate obstacles like stairs and uneven pavement. Powered by a rechargeable battery that can operate up to a full day on a single charge, the wheelchair uses an integrated system of electronic, sensor and software components to automatically adjust itself according to the seat's movement and the user's center of gravity. These components are accompanied by a backup system to assure the safety of the user. It was invented by Dean Kamen, founder of DEKA Research and Development Corporation, best known for the two-wheeled Segway transporter.
