Regulatory Affairs/Drug Approvals News

GSK Update On FDA Review Of Promacta R Eltrombopag

Sat, 21 Jun 2008 22:20:07 GMT

GlaxoSmithKline (NYSE: GSK) announced that the United States Food and Drug Administration has extended the priority review period for PROMACTA(R) (eltrombopag) for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura, as they require more time to review the application.

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FDA Approves GlaxoSmithKline's AVODART R In Combination With Tamsulosin For The Treatment Of Symptomatic Enlarged Prostate

Sat, 21 Jun 2008 22:20:04 GMT

GlaxoSmithKline (NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has approved AVODART (dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged prostate, a disease that affects half of all men over 50 years old.

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FDA Warns Individuals And Firms To Stop Selling Fake Cancer 'Cures'

Fri, 20 Jun 2008 18:20:05 GMT

Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.

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FDA Advisory Committee Unanimously Recommends Approval Of Ustekinumab For Treatment Of Moderate To Severe Plaque Psoriasis

Fri, 20 Jun 2008 18:20:04 GMT

Centocor, Inc. announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.

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FDA Approves Cymbalta reg; For The Management Of Fibromyalgia

Fri, 20 Jun 2008 18:20:03 GMT

The U.S. Food and Drug Administration (FDA) has approved Cymbalta (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company (NYSE: LLY) announced.

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Deaths May Have Been Caused By Abortion Drug's Off-Label Use

Thu, 19 Jun 2008 15:00:11 GMT

Preliminary U-M studies indicate that oral use of RU-486's companion drug misoprostol is safe, but vaginal use may undermine body's immune responsesThe off-label use of a drug given with RU-486 to terminate a pregnancy may be responsible for a handful of rare, fatal infections seen in women taking the drugs since 2000, a study by University of Michigan scientists suggests.

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Nationwide Data Indicate A Very High Degree Of Accuracy For OraQuick ADVANCE Rapid HIV-1 2 Antibody Test With Oral Fluid

Thu, 19 Jun 2008 15:00:10 GMT

OraSure Technologies, Inc. (NASDAQ:OSUR) announced that aggregate nationwide performance data for 2007 and the first five months of 2008 indicate that its widely used rapid HIV-1/2 antibody screening test, OraQuick ADVANCE, has a very high degree of accuracy with oral fluid - at rates that are within the U.

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Cook Medical Enters Coronary Stent Market In Europe With New CoCr Stent

Thu, 19 Jun 2008 15:00:09 GMT

Global Therapeutics, the cardiology unit of Cook Medical, has received CE Mark approval for a new cobalt chromium bare metal coronary stent that company executives believe will fill a demand for non-drug eluting coronary stents among interventional cardiologists, the company announced today.

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Synapse Biomedical Receives FDA Approval Of NeuRx Diaphragm Pacing System DPS TM For Spinal Cord Injury Breathing Applications

Thu, 19 Jun 2008 15:00:08 GMT

Synapse Biomedical Inc. (http://www.synapsebiomedical.com) announced it has received approval from the U.

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European Medicines Agency Recommends Measures To Manage Contamination Ofheparin-Containing Medicines

Tue, 17 Jun 2008 08:00:06 GMT

The European Medicines Agency has reviewed the risks associated with the use of heparin medicinal products contaminated with oversulphated chondroitin sulphate (OSCS).

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