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Vol 66 - February 2010
Featured News

Virtually Everyone Should Get a Flu Shot: CDC

February 2010
All Americans 6 months of age and older should get a flu shot each year, a panel of advisers is recommending. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

VPRIV (velaglucerase alfa) for Injection
Date of Approval: February 26, 2010
Treatment for: Gaucher Disease
VPRIV Drug Information | Press Release

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)
Date of Approval: February 24, 2010
Treatment for: Pneumococcal Disease Prophylaxis
Prevnar 13 Drug Information | Press Release

Cayston (aztreonam lysine) Inhalation Solution
Date of Approval: February 22, 2010
Treatment for: Pneumonia with Cystic Fibrosis
Cayston Drug Information | Press Release

Menveo (meningococcal conjugate vaccine)
Date of Approval: February 19, 2010
Treatment for: Meningococcal Meningitis Prophylaxis
Menveo Drug Information | Press Release

Xiaflex (collagenase clostridium histolyticum)
Date of Approval: February 3, 2010
Treatment for: Dupuytren's Contracture
Xiaflex Drug Information | Press Release

Oleptro (trazodone) Extended Release Tablets
Date of Approval: February 2, 2010
Treatment for: Depression
Oleptro 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.

Mirapex (pramipexole dihydrochloride)
New Dosage Form Approved: February 19, 2010
Now Approved: Mirapex ER for Once-Daily Treatment of Early Parkinson's Disease
Mirapex Drug Information | Press Release

Norvir (ritonavir)
New Formulation Approved: February 10, 2010
Now Approved: Norvir Tablets
Norvir Drug Information | Press Release

Rituxan (rituximab) Injection for Intravenous Use
New Indication Approved: February 18, 2010
Now Approved for: Chronic Lymphocytic Leukemia
Rituxan Drug Information | Press Release

Crestor (rosuvastatin calcium) Tablets
New Indication Approved: February 8, 2010
Now Approved for: Primary Prevention of Cardiovascular Disease
Crestor Drug Information | Press Release

Benicar (olmesartan medoxomil) Tablets
Patient Population Altered: February 4, 2010
Now Approved for: Children and Adolescents
Benicar 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.

Ibutilide Fumarate Injection
0.1 mg/mL
Approved: January 11, 2010 PharmaForce, Inc.; Bioniche Pharma USA LLC.; GeneraMedix Inc.
Generic for: Corvert

Other Drug News

Penicillin Allergy Might Not Include Related Antibiotic
February 27, 2010
Most patients who have a history of penicillin allergy can safely take antibiotics called cephalosporins, researchers say.

Current Blood Thinners Face Tough Competition
February 26, 2010
New studies provide more proof that the mainstays of anti-clotting therapy, namely warfarin and aspirin, are facing some severe competition from newcomers.

Coffee Drinking May Lower Stroke Risk
February 25, 2010
Regular coffee drinking appears to reduce the risk of stroke, a new study indicates.

Doctors Have Many Ways to Say 'No'
February 22, 2010
When a patient asks for a treatment that a physician doesn't believe will work, savvy doctors say no very, very carefully.

New Technology Could Widen Reach of Vaccines
February 18, 2010
Researchers report that they've developed an inexpensive way to keep vaccines stable without the use of refrigerators or freezers, even in the high temperatures of the tropics.

Rising Use of Medical Technologies Extending Americans' Lives
February 17, 2010
Surging use of improved medical technology, including new drugs, is driving up life expectancy for Americans and driving down rates of major killers such as heart disease and cancer, a new national health report finds.

County-By-County Report Sizes Up Americans' Health
February 17, 2010
Want to know how healthy your county is? Now you can find out.

Most Americans Think It's Others Who Are Unhealthy
February 16, 2010
Despite rising rates of obesity and diabetes, a new survey has found that a majority of Americans believe their health is just fine - it's everyone else who has the problem.

Even if You're Careful, Drugs Can End up in Water
February 8, 2010
The federal government advises throwing most unused or expired medications into the trash instead of down the drain, but they can end up in the water anyway, a study from Maine suggests.

Flawed Autism Study Retracted by Medical Journal
February 2, 2010
The prestigious British medical journal The Lancet has formally retracted a highly controversial study that had linked the measles, mumps and rubella vaccine to autism and gastrointestinal problems.

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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