Quantcast
Last updated on April 17, 2014 at 11:32 EDT

Latest Off-label use Stories

59a9f5fb4e2ee2c31c1b5b9d0acc1cc91
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...

3c5ded79e8c7ca9f0ae6db5d138dbf5c1
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doctors use to get important information about indications and reimbursement for use of cancer drugs off-label may be out-of-date and incomplete, according to a study led by researchers in the Duke Comprehensive Cancer Center.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...

92604257f5e8cb392d09c3cb7829cc151
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...

2009-01-15 09:43:00

$515 Million Criminal Fine is Largest Individual Corporate Criminal Fine in History; Civil Settlement Up To $800 Million WASHINGTON, Jan. 15 /PRNewswire-USNewswire/ -- American pharmaceutical giant Eli Lilly and Company today agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa for uses not approved by the Food and Drug Administration (FDA), the Department of Justice announced today. This resolution includes a criminal fine of $515 million, the largest ever in a...

2008-12-30 12:29:00

WASHINGTON, Dec. 30 /PRNewswire-USNewswire/ -- The Coalition for 21st Century Medicine strongly opposes the citizen petition filed by Genentech, Inc. on December 5, 2008, seeking to restrict the ability of laboratories to offer diagnostic tests to physicians and patients. The request threatens innovation in laboratory tests, would harm patient care and rests on flawed scientific and legal premises. The Coalition's mission is to encourage the research, development, and commercialization of...

2008-12-01 16:20:00

EXTON, Pa., Dec. 1 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Cinryze(TM) C1 Inhibitor (human) as a treatment for acute attacks of hereditary angioedema (HAE). The sBLA is based on a re-analysis and resubmission of data from a pivotal Phase 3 acute treatment study of Cinryze and interim data from an ongoing open label...