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Vol 49 - September 2008
iPhone Edition for Consumers
Featured News

'Street' Drug Use Down, Prescription Drug Abuse Rising: U.S. Report

September 4, 2008
'Street' drug use among young adults in the United States fell significantly in 2007, while abuse of prescription drugs increased fairly dramatically, according to a new U.S. survey.

New Drug Approvals

The following drugs have recently been approved by the FDA.

AdreView (iobenguane I 123)
Date of Approval: September 19, 2008
Treatment for: Detection of Rare Neuroendocrine Tumors
AdreView Drug Information | Press Release

Sancuso (granisetron) Transdermal Patch
Date of Approval: September 12, 2008
Treatment for: Nausea/Vomiting - Chemotherapy Induced
Sancuso Drug Information | Press Release

Nplate (romiplostim)
Date of Approval: August 22, 2008
Treatment for: Thrombocytopenia in Idiopathic (Immune) Thrombocytopenic Purpura Patients
Nplate Drug Information | Press Release

More FDA Approvals

New Indications and Dosage Forms

Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.

Nasacort AQ (triamcinolone acetonide) Nasal Spray
Patient Population Altered: September 19, 2008
Treatment for: Allergic Rhinitis in Pediatric Patients 2-5 years
Nasacort AQ Drug Information | Press Release

ProAir HFA (albuterol sulfate) Inhalation Aerosol
Patient Population Altered: September 16, 2008
Treatment for: Asthma in Pediatric Patients 4-11 years
ProAir HFA Drug Information | Press Release

Gamunex (immune globulin intravenous (human)) Injection
New Indication Approved: September 12, 2008
Treatment for: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Gamunex Drug Information | Press Release

Keppra XR (levetiracetam) Extended-Release Tablets
New Dosage Form Approved: September 12, 2008
Treatment for: Partial Onset Seizures
Keppra Drug Information | Press Release

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)
New Indication Approved: September 12, 2008
Treatment for: Prevention of Vulvar and Vaginal Cancers
Gardasil Drug Information | Press Release

Velcade (bortezomib)
New Indication Approved: September 8, 2008
Treatment for: Previously Untreated Multiple Myeloma
Velcade Drug Information | Press Release

Omnitrope Pen 10 With Liquid Cartridge (somatropin (rDNA origin))
New Formulation Approved: August 25, 2008
Treatment for: Growth Disorders
Omnitrope Drug Information | Press Release

First Time Generic Approvals

First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace.

Galantamine Tablets USP 4 mg, 8 mg and 12 mg
Approved: August 28, 2008 Barr Laboratories, Inc.; Alphapharm Pty Ltd.
Generic for: Razadyne Tablets

Other Drug News

The latest Pharmaceutical News & Articles brought to you by Drugs.com

New Diabetes Drug Works Well in Trial
September 25, 2008
One of a new class of diabetes drugs has done well in a trial conducted to help bring it to market, researchers report.

Most Medicare Drug Premiums Same or Lower in 2009
September 25, 2008
In 2009, premiums will not rise for 97 percent of the 10.5 million enrollees in Medicare's "stand-alone" drug plans, which only offer drug coverage...

U.S. Kids Take More Psychotropic Drugs Than Europeans
September 24, 2008
American children are three times more likely to be prescribed psychotropic medications for conditions such as ADHD and bipolar disease than European children are, a new study finds.

Leading COPD Drugs Tied to Stroke, Heart Attack
September 23, 2008
Common drugs prescribed for chronic obstructive pulmonary disease (COPD) are associated with an increased risk of heart attack, stroke and other cardiovascular problems, researchers report.

FDA Bars Generic Drugs From Indian Company
September 16, 2008
More than 30 generic drugs made by Indian drug maker Ranbaxy Laboratories Ltd. are being denied entry into the United States due to quality concerns at two of the company's factories...

Most U.S. Kids Getting Recommended Vaccinations
September 4, 2008
The vast majority of American children are getting their recommended vaccinations. According to the U.S. Centers for Disease Control and Prevention, immunization rates remain at or near record levels...

Kids' Fever Time Cut Using Ibuprofen First
September 3, 2008
Fever in young children can be reduced for a longer period of time by giving them ibuprofen, according to British researchers.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

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New Drugs - All the latest information on FDA Approvals and recent additions to the database.

News & Articles - Roundup of recent drug-related news and press releases. also latest news from FDA Medwatch service including timely publication of recalls, withdrawals, warnings, and label/packaging changes.

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