Under the terms of the deferred prosecution agreement, Endo Pharmaceuticals Inc. admitted that it intended that Lidoderm be used for unapproved indications and that it promoted Lidoderm to health care providers for those unapproved indications. In a deferred prosecution agreement to resolve the charge, Endo Pharmaceuticals Inc.
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sales managers provided instruction to certain sales representatives concerning how to expand sales conversations with doctors beyond PHN and encouraged promotion of Lidoderm in workers’ compensation clinics. The information further alleges that certain Endo Pharmaceuticals Inc. These uses were intended by Endo Pharmaceuticals Inc. was misbranded because its labeling lacked adequate directions for use in the treatment of non-PHN related pain, including low back pain, diabetic neuropathy and carpal tunnel syndrome. The information alleges that, during the relevant time period, the Lidoderm distributed nationwide by Endo Pharmaceuticals Inc. During the period of 2002 to 2006, Lidoderm was approved by the FDA only for the relief of pain associated with post-herpetic neuralgia (PHN), a complication of shingles. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses. The FDCA requires a company, such as Endo Pharmaceuticals Inc., to specify the intended uses of a product in its new drug application to the FDA. introduced into interstate commerce Lidoderm that was misbranded under the Federal Food, Drug and Cosmetic Act (FDCA). In a criminal information filed today in the Northern District of New York, the government charged that, between 20, Endo Pharmaceuticals Inc. “We will hold accountable those who circumvent that process in pursuit of financial gain.”
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“FDA’s drug approval process is designed to ensure that companies market their products for uses that are proven to be safe and effective,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. is a Delaware corporation headquartered in Malvern, Pa.
The resolution includes a deferred prosecution agreement and forfeiture totaling $20.8 million and civil false claims settlements with the federal government and the states and the District of Columbia totaling $171.9 million. (Endo) have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Justice Department announced today. and its subsidiary Endo Pharmaceuticals Inc. The data presented on this page does not represent the view of Endo Pharmaceuticals Inc and its employees or that of Zippia.Įndo Pharmaceuticals Inc may also be known as or be related to ENDO HEALTH SOLUTIONS INC., Endo Health Solutions Inc, Endo Health Solutions Inc., Endo International plc, Endo Pharmaceuticals and Endo Pharmaceuticals Inc.Pharmaceutical company Endo Health Solutions Inc. None of the information on this page has been provided or approved by Endo Pharmaceuticals Inc. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets.
The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. The employee data is based on information from people who have self-reported their past or current employments at Endo Pharmaceuticals Inc. Zippia gives an in-depth look into the details of Endo Pharmaceuticals Inc, including salaries, political affiliations, employee data, and more, in order to inform job seekers about Endo Pharmaceuticals Inc.
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