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Latest Off-label use Stories

2010-05-03 11:59:00

Reglan, metoclopramide never approved for use in infants HOUSTON, May 3 /PRNewswire-USNewswire/ -- Recently, researchers have observed a disturbing trend in neonatal units across the country: doctors prescribing Reglan -- also known by its generic name, metoclopramide -- to treat premature infants. This alarming development has raised serious concerns from many consumer safety advocates, particularly because the drug was never approved for use in infants. Reglan (metoclopramide) was...

2010-04-29 11:31:00

Epilepsy Drug Approved by FDA Promoted for Psychiatric Uses WASHINGTON, April 29 /PRNewswire-USNewswire/ -- American pharmaceutical manufacturers Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., both subsidiaries of Johnson & Johnson, have agreed to pay more than $81 million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Topamax, the Justice Department announced today. According to the agreement reached...

2010-04-27 15:01:00

Sheller, P.C. is Primary Counsel for Record-Breaking $520 Million Civil Settlement; Firm Instrumental in Recovering More Than $4.2 Billion in Pharma Settlements in the Last 15 Months PHILADELPHIA, April 27 /PRNewswire-USNewswire/ -- AstraZeneca will pay the federal government $520 million in civil fines to settle charges of off-label marketing of the powerful antipsychotic drug Seroquel. The settlement is the largest pharmaceutical civil settlement and among the top five civil and criminal...

2010-04-27 13:34:00

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...

2010-03-08 16:57:20

Use of medications injected directly into the eye appears to be an increasingly common treatment for age-related macular degeneration in one region of Canada, but only a small proportion of ophthalmologists perform the procedure, according to a report in the March issue of Archives of Ophthalmology, one of the JAMA/Archives journals. Age-related macular degeneration is the leading cause of blindness in Western nations, according to background information in the article. The development of...

2010-01-11 20:57:42

A study published today in the Archives of Internal Medicine examines the impact of a safety warning issued by the Food and Drug Administration for commonly prescribed antipsychotic medications. The results show the warnings resulted in a decline in usage among the elderly with dementia, yet raise the question as to whether the FDA's system of communicating these warnings is sufficiently targeted and effective. "Because this medication class has limited evidence of benefit among the elderly...

2010-01-11 06:31:00

EXTON, Pa., Jan. 11 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that Vincent Milano, president and chief executive officer of ViroPharma, will provide an overview of the company's business and present a financial update during the 28th Annual J.P. Morgan Healthcare Conference. As previously announced, this presentation will be webcast live at 11:00 A.M. ET (8:00 A.M. PT) on Wednesday, January 13, 2010 and may be accessed via the company's website at...

2010-01-11 06:30:00

EXTON, Pa., Jan. 11 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that it has signed an agreement with Sanquin Blood Supply Foundation for rights to develop, file regulatory dossiers, and commercialize Cinryze(TM) (C1 esterase inhibitor [human]) for hereditary angioedema (HAE) as well as for potential new indications in certain European and rest of world (ROW) territories. This agreement significantly expands ViroPharma's rights to commercialize Cinryze...

2009-10-16 16:41:00

BOSTON, Oct. 16 /PRNewswire-USNewswire/ -- PHARMACIA & UPJOHN COMPANY, INC., a subsidiary of Pfizer Inc. ("Pfizer") today was sentenced today in federal court for a felony violation of the Food, Drug & Cosmetic Act, for misbranding the drug, Bextra, with the intent to defraud or mislead. PHARMACIA & UPJOHN COMPANY, INC. was sentenced by United States District Judge Douglas P. Woodlock to pay a criminal fine of $1.195 billion and a criminal forfeiture of $105 million, for a...

2009-10-10 07:50:30

Investigators from Boston University School of Medicine (BUSM) and the VA Boston Healthcare System have shown, at 6 months in a small group of patients, that there is no difference in efficacy between Bevacizumab (Avastin) and Ranibizumab (Lucentis) for the treatment of age-related macular degeneration (AMD). The study, which appears currently on-line in the American Journal of Ophthalmology, is the first to report early outcomes of a prospective, double-masked, randomized, controlled trial...


Word of the Day
endocarp
  • The hard inner (usually woody) layer of the pericarp of some fruits (as peaches or plums or cherries or olives) that contains the seed.
This word comes from the Greek 'endon,' in, within, plus the Greek 'kardia,' heart.
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