Drug Administration Archives - Lets Talk Health

FDA approves new use for Roche’s Avastin in colon cancer treatment

01/23/2013 majac Your Health Matters

(Reuters) – The U.S. Food and Drug Administration on Wednesday approved the use of Roche’s Avastin for patients whose colorectal cancer has worsened despite previous treatment with the drug. The new use will allow patients first treated with Avastin plus chemotherapy to be treated again with the biotechnology drug in combination with a different chemotherapy regimen. A pivotal clinical trial showed that such a treatment strategy improved survival. …

Drug Administration, FDA, Roche Avastin

Changing food labels could boost understanding

01/23/2013 majac Your Health Matters

NEW YORK (Reuters Health) – Alternative nutrition labels that clearly display the total number of calories and other nutrients in an entire package might help consumers make healthier food choices, according to a new study from the U.S. Food and Drug Administration. FDA researchers found people were best at assessing chips and frozen meals – and comparing the healthfulness of multiple products – when nutrition facts were presented for the entire container’s worth of food or for both one serving and the whole container. …

Drug Administration, FDA

FDA Says Ambien Dosage is to Be Lowered for Women

01/11/2013 majac Your Health Matters

The U.S. Food and Drug Administration issued a statement on Thursday revealing its decision to require that the makers of zolpidem, a common sleep aid drug, reduce the dosage that is given to patients, particularly women. The FDA issued the mandate due to the emergence of information that has shown that the drug can stay in a person’s system for several hours after they wake up.

Drug Administration

FDA: Cut Ambien Dosage for Women

01/10/2013 majac Your Health Matters

The U.S. Food and Drug Administration has announced today that it is requiring manufacturers of Ambien, Ambien CR, Zolpimist, Edluar, and other sleeping medications that contain the active ingredient zolpidem, to lower currently recommended doses.

Drug Administration, FDA

FDA requires lower doses for sleep medications

01/10/2013 majac Your Health Matters

WASHINGTON (AP) — The Food and Drug Administration is requiring makers of Ambien and similar sleeping pills to lower the dosage of their drugs, based on studies suggesting patients face a higher risk of injury due to morning drowsiness.

Drug Administration, FDA

FDA advisory panel backs J&J diabetes drug approval

01/10/2013 majac Your Health Matters

(Reuters) – A panel of advisers to the U.S. Food and Drug Administration recommended the agency approve an experimental new treatment for diabetes developed by Johnson & Johnson, potentially making it the first drug of its type to be approved in the United States. …

Drug Administration, FDA, Johnson Johnson, United States

FDA Cuts Ambien Dosage After Sleep-Driving Incidents

01/10/2013 majac Your Health Matters

Drug Administration

Drugmakers report U.S. shortages of flu vaccine, Tamiflu

01/10/2013 majac Your Health Matters

(Reuters) – This year's U.S. flu season has created shortages of the Tamiflu treatment for children and of the most widely used flu vaccine, their manufacturers said. Roche Holding AG told Reuters late on Wednesday that it had a shortage of the liquid form of Tamiflu, given to children who already have the flu to slow or stop symptoms. A spokeswoman for the U.S. Food and Drug Administration confirmed that there have been supply interruptions in some locations. Roche said it told wholesalers and distributors in recent weeks that temporary delays in shipments were imminent. …

Drug Administration

Teva questions safety of MS drug from rival Biogen

01/09/2013 majac Your Health Matters

(Reuters) – Teva Pharmaceutical Industries Ltd, which makes the market-leading multiple sclerosis drug Copaxone, has filed a petition with the U.S. Food and Drug Administration that could, if granted, delay entry to the market of a rival drug developed by Biogen Idec Inc. Teva’s petition asks that the FDA not approve any new multiple sclerosis drug until its safety has been evaluated by a panel of outside advisors, and said it had uncovered “troubling information” on a publicly accessible website about the safety of Biogen’s drug, BG-12. …

BG, Biogen Idec Inc, Drug Administration, MS

FDA: New rules will make food safer

01/05/2013 majac Your Health Matters

WASHINGTON (AP) — The Food and Drug Administration says its new guidelines would make the food Americans eat safer and help prevent the kinds of foodborne disease outbreaks that sicken or kill thousands of consumers each year.

Drug Administration, FDA

FDA proposes sweeping new food safety rules

01/04/2013 majac Your Health Matters

WASHINGTON (AP) — The Food and Drug Administration on Friday proposed the most sweeping food safety rules in decades, requiring farmers and food companies to be more vigilant in the wake of deadly outbreaks in peanuts, cantaloupe and leafy greens.

Drug Administration, FDA

New U.S. food safety rules by FDA seek more accountability

01/04/2013 majac Your Health Matters

(Reuters) – U.S. regulators proposed new food safety rules on Friday that aim to make food processors and farms more accountable for reducing food borne illnesses that kill or sicken thousands of Americans annually. The rules, required by the Food Safety Modernization Act (FSMA) that was signed into law two years ago, were announced by the U.S. Food and Drug Administration on Friday. The agency has come under heavy criticism for failing to introduce new food safety rules faster, but many of those critics applauded FDA’s announcement. …

Drug Administration, FDA

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