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Latest Off-label use Stories

2009-08-21 08:31:54

Physicians lack knowledge of off-label drug use and FDA approval statusIn a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration. This mistaken belief could encourage them to prescribe these drugs, despite the lack of scientific evidence supporting such use."Off-label prescribing is common, but researchers have not always known why. Our research shows that some...

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2009-06-25 11:20:00

Consumer advocate groups said on Wednesday that the U.S. Food and Drug Administration should make more information available to the public, even on drugs and devices that never make it to the U.S. market, Reuters reported. But findings or data containing confidential company information could harm competition if made widely available, according to industry representatives. Several advocates and former FDA staff reviewers said that while the FDA often provides public details on products that...

2009-06-16 16:33:00

PHILADELPHIA, June 16 /PRNewswire-USNewswire/ -- United States Attorney Michael L. Levy and Acting Assistant Attorney General Michael F. Hertz today announced the return of an indictment(1.) against Norian Corporation (Norian), Synthes, Inc. (Synthes), and four top Synthes executives, Michael D. Huggins (Huggins), Thomas B. Higgins (Higgins), Richard E. Bohner (Bohner) and John J. Walsh (Walsh), charging them for their involvement in conducting clinical trials of a medical device without the...

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2009-06-11 06:15:18

Although psychiatric drugs in children and adolescents can increase the risk of diabetes, Food and Drug Administration advisers still claim the drugs seem safe and effective for treatment of certain conditions, the Associated Press reported.  Drugs by AstraZeneca, Eli Lilly and Pfizer are seemingly safe and beneficial for the treatment of schizophrenia and bipolar disorder in individuals ages 10 to 17, according to an overwhelmingly supportive vote by the FDA's panel of experts. ...

2009-06-04 06:30:00

- Company Also Granted Expansion of Prophylaxis Therapy Label to Include Patient Labeling for Self-Administration - EXTON, Pa., June 4 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) related to its supplemental Biologics License Application (sBLA) for Cinryze(TM) (C1 esterase inhibitor [human]) as a treatment for acute attacks of hereditary angioedema (HAE). The...

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2009-06-03 09:32:53

The U.S. Food and Drug Administration has approved the first drug developed specifically for the treatment of cancer in dogs. The FDA said Palladia (toceranib phosphate) has been approved to treat canine cutaneous mast cell tumors, a type of cancer responsible for about 1 of 5 cases of canine skin tumors. All cancer drugs currently used in veterinary medicine originally were developed for use in humans and are not approved for use in animals, the federal agency said. Cancer treatments used in...

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2009-05-20 12:52:08

New charges in the ongoing lawsuit against British drugmaker AstraZeneca suggest that market executives blocked company scientists from raising concerns that the antipsychotic drug Seroquel caused weight gain and other problems, The Associated Press reported. Plaintiff lawyers say the company researchers were forbidden for years to reveal such concerns because it would harm sales of the drug. They maintain that internal documents released Wednesday back these claims. Patients of the drug for...

2009-03-24 07:00:00

LANSDALE, Pa., March 24 /PRNewswire/ --- As the Food and Drug Administration (FDA) approves new cancer fighting drugs for the market, researchers often study their use for non-approved, or off-label, treatments. When the studies show promise for combating other forms of cancer, physicians may prescribe these drugs to patients. By some estimates, nearly 20 percent of all drugs prescribed in the United States are for off-label use. Oncologists prescribe cancer drugs off-label about 60 percent...

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2009-03-05 08:35:00

A recent study in Oregon suggests that drugs designed for treating the most severe mental illnesses are often prescribed at inappropriately low doses and at considerable expense, for use in conditions where their benefit has not been established. In this case, prescription drugs that might cost as much as $20 to $25 a day were being widely used to treat problems for which they were not FDA-approved. Some of those problems could have been addressed with generic medications costing $1 a day,...

2009-02-19 11:47:00

Pharmaceutical Companies Allegedly Marketed the Drug Natrecor for a Use Not Approved By the Food and Drug Administration WASHINGTON, Feb. 19 /PRNewswire-USNewswire/ -- The United States has intervened in two whistleblower suits filed in the Northern District of California against the drug manufacturer Scios Inc. and its parent company, Johnson & Johnson Inc., alleging that the companies marketed the cardiac drug Natrecor for a use not approved by the Food and Drug Administration (FDA)...


Word of the Day
conjunto
  • A style of popular dance music originating along the border between Texas and Mexico, characterized by the use of accordion, drums, and 12-string bass guitar and traditionally based on polka, waltz, and bolero rhythms.
The word 'conjunto' comes through Spanish, from Latin coniūnctus, past participle of coniungere, to join together; see conjoin