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Consumer Information on: OraQuick HCV Rapid Antibody Test - P080027

July 30, 2010 5:32 pm | by U.S. Food & Drug Administration | Comments

The OraQuick HCV Rapid Antibody Test is used to detect a patient?s exposure to the hepatitis C virus (HCV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies...

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Summary Information for: OraQuick HCV Rapid Antibody Test

July 30, 2010 5:32 pm | by U.S. Food & Drug Administration | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for OraQuick HCV Rapid Antibody Test (P080027).

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NICE Recommends First Device Under New Technology Pathway

July 30, 2010 5:31 pm | by U.S. Food & Drug Administration | Comments

The UK's National Institute for Health and Clinical Excellence (NICE) has given a provisional nod to B. Braun Medical's SeQuent Please balloon catheter for use in patients with in-stent restenosis in bare metal coronary artery stents, following the recommendation of the...

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FDA Extends Comment Period on Reclassification Rule

July 30, 2010 5:31 pm | by U.S. Food & Drug Administration | Comments

The FDA is giving devicemakers more time to comment on a proposed rule that would reclassify some devices as Class II and amend the regulations to establish special controls for others.

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Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach

July 30, 2010 5:31 pm | by U.S. Food & Drug Administration | Comments

Product sold online as a dietary supplement. When consumed as instructed, produces an industrial bleach that can cause serious harm to health.

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Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure

July 30, 2010 5:30 pm | by U.S. Food & Drug Administration | Comments

Increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.

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3M, Vosschemie resolve patent dispute

July 30, 2010 2:45 pm | by The Associated Press | Comments

3M Co. and Vosschemie GmbH said Friday they have settled a patent infringement lawsuit that 3M filed last November.The case involves a patent 3M owns concerning its Paint Preparation Systems products. 3M manufactures and sells a disposable cup paint mixing system under its PPS brand.Vosschemie...

Perrigo Confirms Filing for Generic Version of Gynazole-1® Cream and Announcement of Patent Infringement Lawsuit by KV Pharma

July 30, 2010 12:40 pm | by Bio-Medicine.Org | Comments

ALLEGAN, Mich. , July 30 /- Perrigo Company (Nasdaq: PRGO;TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for butoconazole nitrate vaginal cream, 2% and that is has notified KV Pharmaceutical Company, the owner...

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FDA Approves Vaccines for the 2010-2011 Influenza Season

July 30, 2010 12:40 pm | by Bio-Medicine.Org | Comments

SILVER SPRING, Md. , July 30 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration announced today that it has approved vaccines for the 2010-2011 influenza season in the United States . (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO ) (Logo: http://www.newscom....

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Mylan Announces Pricing of Add-On Offering of Senior Notes

July 30, 2010 12:40 pm | by Bio-Medicine.Org | Comments

PITTSBURGH , July 30 /- Mylan Inc. (Nasdaq: MYL ) today announced that it priced $300 million aggregate principal amount of Senior Notes due 2020 at an issue price of 105.5% with a coupon of 7.875%, or an effective yield to maturity of 7.087%. The notes are being offered as additional...

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WuXi PharmaTech RESCHEDULES Second-Quarter 2010 Earnings Conference Call

July 30, 2010 12:39 pm | by Bio-Medicine.Org | Comments

SHANGHAI , July 30 /PRNewswire-Asia/ -- WuXi PharmaTech (Cayman) Inc. (NYSE: WX ), a leading pharmaceutical, biotechnology and medical device R&D outsourcing company with operations in China and the United States , today announced that it will release financial results for the second...

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Conatus Pharmaceuticals Acquires Pfizer's Idun Subsidiary

July 30, 2010 12:39 pm | by Bio-Medicine.Org | Comments

SAN DIEGO , July 30 /- Conatus Pharmaceuticals Inc. announced today that Conatus acquired the Idun Pharmaceuticals subsidiary of Pfizer Inc.  Financial terms were not disclosed.  Conatus Pharmaceuticals is a privately-held drug development company focused on liver disease and...

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CareFusion Will Host an Earnings Conference Call on Aug. 10 to Discuss the Results for the Fourth Quarter and Fiscal 2010

July 30, 2010 12:39 pm | by Bio-Medicine.Org | Comments

SAN DIEGO , July 30 /- CareFusion Corporation (NYSE: CFN ) today announced plans to release fourth quarter and fiscal 2010 results on Tuesday, Aug. 10 following the close of trading on the New York Stock Exchange. The company will host a webcast and conference call on Aug. 10 at 2 p.m....

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Texas Children's Hospital and Baylor College of Medicine Report Stolen Laptop

July 30, 2010 12:38 pm | by Baylor College of Medicine | Comments

On May 13, 2010, a physician from Baylor College of Medicine and affiliated with Texas Children's Hospital had his password-protected laptop stolen from an office at Texas Children's Hospital in Houston, Texas. Electronic files on the laptop contained demographic and clinical information...

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Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient

July 30, 2010 12:31 pm | by U.S. Food & Drug Administration | Comments

These products, marketed as dietary supplements, contain sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerously low levels.

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