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Latest Off-label use Stories

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...

2008-11-25 16:47:04

Doctors and patients should be concerned about antipsychotic and antidepressant drugs being prescribed for unapproved conditions, U.S. researchers said. The off-label prescribing is a legal, common practice that is raising questions because of the lack of scientific evidence supporting its safety and effectiveness, USA Today reported Tuesday. Although previous research has highlighted the substantial frequency of off-label drug use without good evidence, we have identified and prioritized...

2008-10-29 00:00:05

Two physicians describe how some drug companies may promote off-label use -- prescribing drugs for a purpose outside of their approved use. Adriane Fugh-Berman of Georgetown University Medical Center and Douglas Melnick, a physician working in Hollywood, Calif., write in the journal PLoS Medicine that while off-label drug use is "sometimes unavoidable" and sometimes "demonstrably beneficial," it also has been linked to serious side effects. Off-label drug use "should be undertaken with...

2008-10-28 06:00:28

By Rita Rubin Baylor College of Medicine neurologist Joseph Jankovic is a patient man. With the Food and Drug Administration's OK, Jankovic has studied the drug tetrabenazine since 1979. Over the years, he estimates, he has dispensed tetrabenazine -- or TBZ, as he calls it -- to 1,000 people with Huntington's disease, probably more than any doctor in the world. Tetrabenazine helps tame the uncontrollable movements, or "chorea," that characterize Huntington's, an inherited...

2008-09-29 14:40:56

WASHINGTON, Sept. 29 /PRNewswire/ -- The government's investigation into Cephalon Inc.'s illegal marketing practices that culminated in today's $425,000,000 settlement and guilty plea by the pharmaceutical company began in January 2003 with a Cephalon sales representative in Ohio. The sales representative, Bruce Boise, refused to follow company-ordered sales strategies to convince doctors to prescribe Cephalon's Actiq, Gabitril and Provigil drugs for unapproved ("off-label') uses because...

2008-09-29 14:40:56

To: NATIONAL EDITORS Contact: U.S. Department of Justice, +1-202-514-2007, TDD +1-202- 514-1888 WASHINGTON, Sept. 29 /PRNewswire-USNewswire/ -- Cephalon Inc. will enter a criminal plea and pay $425 million to resolve claims that it marketed three drugs for uses not approved by the Food and Drug Administration (FDA), the Justice Department announced today. The lawsuits were brought by former Cephalon employees and filed under thequi tamprovisions of the False Claims Act. The suits...

2008-09-23 06:00:11

In a new paper published in the online open-access journal PLoS ONE, http://dx.plos.org/10.1371/journal.pone.0003150, David Pickar and colleagues of Gabriel Sciences report that 74.5% of 200 community-based schizophrenic patients, who were individually interviewed and evaluated (including a review of clinical records), were treated with off-label medication treatments. Specifically, 42.5% of subjects reported that they were simultaneously treated with more than one antipsychotic drug, an...

2008-09-17 12:00:11

To: NATIONAL EDITORS Contact: Michael Levin-Epstein, Editor-in-Chief of FDLI, +1-202- 222-0897, mdl@fdli.org WASHINGTON, Sept. 17 /PRNewswire-USNewswire/ -- More than ever, physicians in the United States are prescribing drugs, biologics and devices to treat patients in ways that were not specifically approved by FDA. This treatment often is in response to patients' increasing demand for access to drugs and devices that promise hope for treating diseases but that have not yet been...


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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