Navigation Links
Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing
Date:4/27/2010

WASHINGTON, April 27 /PRNewswire-USNewswire/ -- AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Departments of Justice and Health and Human Services' Health Care Fraud Enforcement Action Team (HEAT) announced today.  Such unapproved uses are also known as "off-label" uses because they are not included in the drug's FDA approved product label.

The Wilmington, Del.-based company signed a civil settlement to resolve allegations that by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.

Under the terms of the settlement, the federal government will receive $301,907,007 from the civil settlement, and the state Medicaid programs and the District of Columbia will share up to $218,092,993 of the civil settlement, depending on the number of states that participate in the settlement. The allegations were originally brought in a lawsuit under the qui tam or whistleblower provisions of the False Claims Act and various state False Claims Act statutes.

Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA.  Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the
'/>"/>

SOURCE U.S. Department of Justice
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
2. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
3. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
4. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
7. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
8. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
9. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
10. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
11. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/16/2014)... , Sept. 16, 2014 Imprimis Pharmaceuticals, Inc. ... dedicated to delivering high quality and novel medicines to ... Chief Executive Officer Mark Baum will be ... Alpha Select Conference in New York City.  Mr. Baum ... Go Dropless™ campaign in ophthalmology. The presentation is scheduled ...
(Date:9/16/2014)... , Sept. 16, 2014  Wearable sports and ... in less than two years, producing a massive ... A huge opportunity exists for leveraging this data ... http://vivametrica.com/our-video/ ) introduced a first-of-its-kind wearable analytics platform ... years of clinical research linking activity and health ...
(Date:9/16/2014)... 2014 Henry Schein, Inc. (NASDAQ: ... health care products and services to office-based dental, ... Stanley M. Bergman, Henry Schein,s Chairman of the Board and ... services panel at the Leerink Partners Services Roundtable on Tuesday, ... Dr. Stohler, Dean of Columbia University,s College of ...
Breaking Medicine Technology:Imprimis Pharmaceuticals to Present at Craig-Hallum Alpha Select Conference 2Imprimis Pharmaceuticals to Present at Craig-Hallum Alpha Select Conference 3Imprimis Pharmaceuticals to Present at Craig-Hallum Alpha Select Conference 4Doctors Launch Initiative to Bridge Gap Between Wearables and Meaningful Health Data 2Doctors Launch Initiative to Bridge Gap Between Wearables and Meaningful Health Data 3Henry Schein To Present At The Leerink Partners Services Roundtable 2
... III Study Provides Further Evidence of,the Significant ... Treatment,of Rheumatoid Arthritis, BASEL, Switzerland, June 6, ... multinational phase III Actemra,(tocilizumab) study, successfully reached ... proportion of patients treated with Actemra,in combination ...
... Topical Therapy Reduces TNF-alpha Production Through Inhibition,of ... 2007 /PRNewswire/ -- Anacor,Pharmaceuticals, a privately held ... placebo-controlled Phase 1 trial of,AN2728, a first-in-class ... psoriasis. The trial showed AN2728 to be,well-tolerated, ...
Cached Medicine Technology:New Data Confirms Significant Improvement of Disease Signs and,Symptoms in Patients with Rheumatoid Arthritis 2New Data Confirms Significant Improvement of Disease Signs and,Symptoms in Patients with Rheumatoid Arthritis 3New Data Confirms Significant Improvement of Disease Signs and,Symptoms in Patients with Rheumatoid Arthritis 4Anacor Clinical Study of AN2728, a Novel Anti-Inflammatory,Compound, Shows Efficacy in Psoriasis 2
(Date:9/16/2014)... Seven heroes who have dramatically improved the ... in New York City on November 6 by World ... recognition and funding program that honors individuals serving vulnerable ... the “Nobel Prize for Child Advocates,” this year’s selection ... benefit children in countries around the world dealing with ...
(Date:9/16/2014)... Who:, The Pulmonary Hypertension Association (PHA), ... Children’s Hospital Colorado are hosting Colorado PH in the ... association that works to find ways to prevent and cure ... affects the functioning of the heart and can lead to ... years. , What:, Colorado PH in the Park 2014 ...
(Date:9/16/2014)... 2014 As part of its Latinos ... Citizens (LULAC) will host the second annual health festival ... feature free health screenings for osteoporosis, HIV, and high ... and cholesterol levels as well as bone marrow typing. ... under 6 years old , The event will also ...
(Date:9/16/2014)... women older than 70 in national breast cancer screening ... forms of the disease, a new study finds. ... in older women being overdiagnosed and overtreated, the Dutch ... women for breast cancer should be made on a ... screening, the decision to participate in the screening program ...
(Date:9/16/2014)... HealthDay Reporter TUESDAY, Sept. ... cancer survivors are alive today, compared to just 3 ... reported Tuesday. These individuals amount to 4 percent ... childhood cancer, according to the association,s annual progress report. ... treatment of cancer and details some of the challenges ...
Breaking Medicine News(10 mins):Health News:World of Children® Award Announces 2014 Honorees 2Health News:World of Children® Award Announces 2014 Honorees 3Health News:World of Children® Award Announces 2014 Honorees 4Health News:World of Children® Award Announces 2014 Honorees 5Health News:World of Children® Award Announces 2014 Honorees 6Health News:World of Children® Award Announces 2014 Honorees 7Health News:World of Children® Award Announces 2014 Honorees 8Health News:Help Fight Pulmonary Hypertension at the Colorado PH in the Park 2014 2Health News:LULAC Hosts Second Annual Latinos Living Healthy Feria de Salud in Los Angeles 2Health News:Some Benefits of Screening Elderly Women for Breast Cancer Questioned 2Health News:Targeted Drugs Among Successes Against Cancer, Says New Report 2Health News:Targeted Drugs Among Successes Against Cancer, Says New Report 3Health News:Targeted Drugs Among Successes Against Cancer, Says New Report 4
... ... in Financial Journalism Award from the New York State Society of Certified Public Accountants (NYSSCPA). ... New York, NY (PRWEB) ... CFO magazine , won an Excellence in Financial Journalism Award from the New York State ...
... ... leading provider of Semantic Web infrastructure technologies announced today that it has entered ... ... 2010 -- Intellidimension, Inc. a leading provider of Semantic Web infrastructure technologies announced ...
... ... response services and solutions, has introduced iCAN, a feature-rich, streamlined approach to automated telephony services. ... up fees and extremely quick turnaround times to start up. , ... Buffalo, New York (Vocus) April 6, 2010 -- ...
... ... Many important secrets have been kept from the public about ... unknown players in the health care reformation debacle. Author of "The ... of the insights contained in his new work, now available on ...
... report disabilities related to mobility increased significantly from 1997 to ... found among Americans ages 65 and over, according to a ... Michigan. Researchers found a rise in the proportion of ... the need for help in daily personal care activities such ...
... of Wisconsin-Madison, one of the most powerful magnetic ... pregnant patients for rare but very serious fetal ... The Medical College of Wisconsin, Milwaukee; Children,s Hospital ... the ultrasensitive detector measures magnetic signals coming from ...
Cached Medicine News:Health News:CFO magazine Wins Excellence in Financial Journalism Award 2Health News:Intellidimension Announces Semantic Web Technology Partnership with Matrikon 2Health News:Intellidimension Announces Semantic Web Technology Partnership with Matrikon 3Health News:IVR Technology Group Announces iCANsm Services 2Health News:Health Care Reform's Hidden Racket Exposed 2Health News:Health Care Reform's Hidden Racket Exposed 3Health News:Health Care Reform's Hidden Racket Exposed 4Health News:Middle-aged Americans reporting more mobility related disabilities, study finds 2Health News:Middle-aged Americans reporting more mobility related disabilities, study finds 3Health News:Ultrasensitive detector pinpoints big problem in tiny fetal heart 2Health News:Ultrasensitive detector pinpoints big problem in tiny fetal heart 3Health News:Ultrasensitive detector pinpoints big problem in tiny fetal heart 4
... Hospitals, correctional facilities, recreational venues ... wristbands to provide automated data capture ... reducing costly and dangerous errors. RFID ... admissions wristbands at entertainment venues as ...
Computer-generated Smart CompuBand can be simultaneously printed with bar code information and programmed with RFID information...
... The optional Kisses component ... designed to assist nursing staff ... mothers while in the hospital. ... you have an easy, effective ...
Safe. Reliable. Baby-friendly. ,The Hugs infant protection system helps to protect your infants and children from the threat of abduction....
Medicine Products: