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Vol 60 - August 2009
Featured News

U.S. Childhood Vaccine Rates Good But Could Be Better: CDC

August 2009
More than three-quarters of United States children have received the recommended vaccinations, but greater efforts are needed to reach youngsters who are not fully immunized, a US government report finds. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Zenpep (pancrealipase) Capsules
Date of Approval: August 27, 2009
Treatment for: Pancreatic Exocrine Dysfunction
Zenpep Drug Information | Press Release

Sabril (vigabatrin) Tablets and Oral Solution
Date of Approval: August 21, 2009
Treatment for: Epilepsy, Seizures
Sabril Drug Information | Press Release

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) Solution for Intramuscular Injection
Date of Approval: August 19, 2009
Treatment for: Haemophilus influenzae Prophylaxis
Hiberix Drug Information | Press Release

Saphris (asenapine) Sublingual Tablets
Date of Approval: August 13, 2009
Treatment for: Schizophrenia, Bipolar Disorder
Saphris Drug Information | Press Release

Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules
Date of Approval: August 13, 2009
Treatment for: Pain
Embeda Drug Information | Press Release

Livalo (pitavastatin) Tablets
Date of Approval: August 3, 2009
Treatment for: High Cholesterol
Livalo Drug Information | Press Release

Lipsovir (acyclovir and hydrocortisone) Topical Cream
Date of Approval: July 31, 2009
Treatment for: Herpes Simplex Labialis
Lipsovir Drug Information | Press Release

New Indications and Dosage Forms

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

Invega (paliperidone)
New Dosage Form Approved: July 31, 2009
Now Approved: Invega Sustenna
Invega Drug Information | Press Release

Invega (paliperidone)
New Indication Approved: July 31, 2009
Now Approved for: Schizoaffective Disorder
Invega Drug Information | Press Release

Avastin (bevacizumab) Injection
New Indication Approved: July 31, 2009
Now Approved for: Metastatic Renal Cell Carcinoma
Avastin Drug Information | Press Release

Xyzal (levocetirizine dihydrochloride)
Patient Population Altered: August 21, 2009
Now Approved for: Allergy Symptoms in Children Six Months and Older
Xyzal 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.

Bicalutamide Tablets
50 mg
Approved: July 6, 2009 Teva Pharmaceuticals; Synthon Pharmaceuticals, Inc.; Kudco; Sandoz; Accord Healthcare Inc.; Zydus Pharmaceuticals; Sun Pharmaceutical Industries Ltd; Mylan Pharmaceuticals
Generic for: Casodex

Other Drug News

Americans Are Urged to Cut Sugar Intake
August 24, 2009
Most American women should not consume more than 100 calories of added sugar a day, while men should limit their intake to no more than 150 calories, according to a new recommendation from the American Heart Association.

Not Everyone Wants to Be Vaccinated Against Pandemic Flu
August 24, 2009
Some people may refuse to get vaccinated against a pandemic virus if they believe the risks outweigh the benefits, suggests a new study.

Abuse of ADHD Drugs on the Rise
August 24, 2009
As more and more prescriptions are being written for medications to treat attention-deficit hyperactivity disorder (ADHD), more and more children are abusing these drugs.

Off-label use: Oft not evidence based
August 21, 2009
In a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration.

School Kids, Parents Should Get Flu Vaccines First
August 20, 2009
The best way to stop the spread of flu, be it the seasonal flu or swine flu, is to vaccinate those most likely to spread the virus, namely school children and their parents, new research suggests.

Patch 'Shots' May Someday Replace Injections
August 19, 2009
A skin patch lined with "microneedles" may someday offer a painless alternative to hypodermic needles, according to scientists working on the concept.

Antibiotics Being Prescribed Less for Respiratory Infections
August 18, 2009
Prescribing antibiotics to treat respiratory tract infections has dropped significantly in recent years, a new study has found.

'Cruise Ship Virus' Vaccine Stems From Tobacco
August 18, 2009
Scientists have developed a vaccine for the common viral infection norovirus from a novel source: a tobacco plant.

Antioxidants Pose No Melanoma Threat
August 17, 2009
Vitamins C, E and other antioxidants do not increase the risk for melanoma, the most serious form of skin cancer, a new study found.

Chewing Tobacco No Safer Than Smoking
August 17, 2009
Tobacco users who think it's safer to dip snuff or chew tobacco than smoke are dead wrong, researchers say.

Survey Finds Binge Drinking Among Older People, Too
August 17, 2009
Binge drinking isn't just a problem of young people, researchers say.

Web Is Becoming One-Stop Shopping for Health Help
August 16, 2009
People regularly turn to the Internet for games and gossip, news and entertainment, essential information and high weirdness.

International Travel Health Guidebook Gets Updated
August 15, 2009
If you are an international traveler, the United States government has a guidebook that could save your life.

They Snooze Less, But They Don't Lose
August 13, 2009
A lucky few can get by just fine on six hours of sleep, and a new study suggests a genetic mutation might help explain why.

FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs
August 13, 2009
The United States Food and Drug Administration published two rules today that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options.

Folk Medicine Therapy May Prevent Alcoholic Relapse
August 12, 2009
A synthetic form of a substance found in the kudzu vine can reduce drinking among alcoholics and help prevent relapse, a new study suggests.

Suicide Risk With Antidepressants Falls With Age
August 11, 2009
The U.S. Food and Drug Administration is doing its part to make sure that doctors and patients alike are aware of the latest data on the link between antidepressant use and suicide, which indicate that the risk declines steadily with age.

Sharing Prescription Meds Common Among U.S. Teens
August 10, 2009
About 20 percent of United States teens exchange prescription drugs such as antibiotics and allergy medications with friends, a practice that can be dangerous and potentially deadly, warns a new study.

In U.S., No Comeback Seen for Hormone Therapy
August 9, 2009
Hormone replacement therapy once seemed like a wonderful means to help women age gracefully.

When Kids Are Hospitalized, Parents Fret About Errors
August 7, 2009
Many parents worry that their child may be the victim of medical errors while in the hospital, a new study has found.

Many Texas Docs Not Pushing HPV Vaccine for Girls
August 6, 2009
More than half of Texas doctors don't always recommend human papillomavirus (HPV) vaccination for girls, despite United States guidelines urging their inoculation, a new survey finds.

U.S. Spending on Mental Health Care Soaring
August 5, 2009
U.S. spending on mental illness is soaring at a faster pace than spending on any other health care category, new government data shows.

Medicines Top Source of Kids' Poisonings
August 4, 2009
The leading cause of accidental poisonings among American children can be found in the family medicine cabinet, a new government report shows.

Antidepressant Use in U.S. Has Almost Doubled
August 3, 2009
Antidepressant use among United States residents almost doubled between 1996 and 2005, along with a concurrent rise in the use of other psychotropic medications, a new report shows.

One in 10 High School Seniors Have Used Narcotic Painkillers
August 3, 2009
Pain relief isn't the main reason why one in 10 high school seniors have tried opioid drugs, a new United States study finds.

More News Headlines

FDA MedWatch Alerts

Update: FDA Warns Tumor Necrosis Factor (TNF) Blockers May Increase Cancer Risk

Update on Leukotriene Inhibitors: Precaution Labeling for Possible Neuropsychiatric Events

Tibotec and FDA Update Warnings for Intelence

FDA Warns Stolen Levemir Insulin May Still Be On Market

Voluntary Nationwide Recall of Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]

FDA Reviewing Reports of Liver Failure with Weight Loss Drug Orlistat (marketed as Alli and Xenical)

Expanded Recall of Steam Dietary Supplement

FDA Issues Warnings on Unapproved Topical Ibuprofen

FDA Warns of Pure Red Cell Aplasia (PRCA) in CellCept Patients

Voluntary Recall of Dextroamphetamine/Amphetamine 20mg Tablets - Barr Laboratories, Inc.

FDA Warns of Potentially Fatal Errors with GDH-PQQ Glucose Monitoring Technology

FDA Warns Tumor Necrosis Factor (TNF) Blockers May Increase Cancer Risk

More FDA Medwatch Alerts

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