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Latest Off-label use Stories

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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)...

2009-02-17 14:28:34

The resources doctors use to get important information about indications and reimbursement for use of cancer drugs off-label may be out-of-date and incomplete, according to a study led by researchers in the Duke Comprehensive Cancer Center. The study, which was funded by the Agency for Healthcare Research and Quality (AHRQ), examined compendia "“ the online and hard copy resources that oncologists and pharmacists use when prescribing medications for diseases other than the ones for...

2009-02-03 11:03:00

- PDUFA Date for Cinryze for Acute HAE Indication is June 3, 2009 - EXTON, Pa., Feb. 3 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Cinryze C1 Inhibitor (human) as a treatment for acute attacks of Hereditary Angioedema (HAE). The supplemental Biologics License Application (sBLA), submitted to the FDA on December 1, 2008, was based on a re-analysis and resubmission of data...

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2009-01-28 09:27:13

Medicare has extended its coverage for cancer drugs to incorporate several treatments that do not have the Food and Drug Administration's approval. The alterations were proclaimed last year without fanfare and took effect shortly after. Doctors and patients who seek Medicare compensation for unusual treatments can forgo negotiation with the billing department for repayment. This will undoubtedly amplify Medicare costs, as cancer medications frequently cost thousands of dollars monthly "In...


Word of the Day
bibliopole
  • A bookseller; now, especially, a dealer in rare and curious books.
This word comes from a Greek phrase meaning 'book seller.'
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