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Vol 64 - December 2009
Featured News

In U.S., Prescription Drug Abuse Is Growing

December 2009
The overdose death of pop star Michael Jackson in 2009 drew new attention to the abuse of prescription drugs in the United States. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Zyprexa Relprevv (olanzapine) for Extended Release Injectable Suspension
Date of Approval: December 11, 2009
Treatment for: Schizophrenia
Zyprexa Relprevv Drug Information | Press Release

Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) Injection
Date of Approval: December 4, 2009
Treatment for: von Willebrand's Disease
Wilate Drug Information | Press Release

Kalbitor (ecallantide) Injection
Date of Approval: December 1, 2009
Treatment for: Angioedema
Kalbitor Drug Information | Press Release

Zegerid OTC (omeprazole and sodium bicarbonate) Capsules
Date of Approval: December 1, 2009
Treatment for: Heartburn
Zegerid OTC 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.

Spiriva HandiHaler (tiotropium bromide) Inhalation Powder
Labeling Revision Approved: December 17, 2009
Now Approved for: Reduction of COPD Exacerbations
Spiriva HandiHaler Drug Information | Press Release

Azilect (rasagiline mesylate) Tablets
Labeling Revision Approved: December 9, 2009
Reduced Medication and Food Restrictions
Azilect Drug Information | Press Release

Fluzone (influenza virus vaccine, inactivated) Suspension for Intramuscular Injection
New Formulation Approved: December 23, 2009
Now Approved: Fluzone High-Dose
Fluzone Drug Information | Press Release

Seroquel XR (quetiapine) Tablets
New Indication Approved: December 2, 2009
Now Approved for: Add-On Treatment of Major Depressive Disorder
Seroquel XR Drug Information | Press Release

Zyprexa (olanzapine)
Patient Population Altered: December 4, 2009
Now Approved for: Schizophrenia and Bipolar I Disorder in Adolescents
Zyprexa 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.

Ketorolac Tromethamine Ophthalmic Solution
0.5%
Approved: November 5, 2009 Alcon Inc.; Akorn Inc.; Sun Pharma Global, Inc.
Generic for: Acular Ophthalmic Solution

Ketorolac Tromethamine Ophthalmic Solution
0.4%
Approved: November 5, 2009 Apotex Inc.; Alcon Inc.; Akorn Inc.
Generic for: Acular LS Ophthalmic Solution

Norethindrone Acetate and Ethinyl Estradiol Tablets
USP, 1 mg/0.005 mg
Approved: November 6, 2009 Barr Laboratories, Inc.
Generic for: Femhrt Tablets 1 mg/0.005 mg

Lansoprazole Delayed-Release Capsules
USP, 15 mg and 30 mg
Approved: November 10, 2009 Teva Pharmaceuticals USA; Matrix Laboratories Limited
Generic for: Prevacid Delayed-Release Capsules

Perindopril Erbumine Tablets
2 mg, 4 mg and 8 mg
Approved: November 10, 2009 Aurobindo Pharma Limited; Roxane Laboratories, Inc.; IVAX Pharmaceuticals, Inc.
Generic for: Aceon Tablets

Tramadol Hydrochloride Extended-Release Tablets
100 mg and 200 mg
Approved: November 13, 2009 Par Pharmaceutical, Inc.
Generic for: Ultram ER Tablets, 100 mg and 200 mg

Nicardipine Hydrochloride Injection
2.5 mg/mL; packaged in 25 mg/10 mL Single-Dise Vials
Approved: November 17, 2009 Generamedix, Inc.; Pharmaforce, Inc.; Navinta, LLC; Sun Pharma Global, Inc.; Wockhardt Limited
Generic for: Cardene I.V. Injection

Nizatidine Oral Solution
15 mg/mL
Approved: November 18, 2009 Amneal Pharmaceuticals
Generic for: Axid Oral Solution

Other Drug News

Sun Protection Advised Year-Round
December 28, 2009
If you're like many people, you slather on sunscreen during hot summer days, then in winter, not so much.

Tylenol May Ease Headaches and Heartaches
December 24, 2009
Acetaminophen, best known as Tylenol, is usually taken to relieve physical pain, but a new study suggests that the over-the-counter drug may also help ease the psychological pain of rejection.

Medication Adherence Varies Between Races
December 18, 2009
Elderly black Americans use fewer medications than whites and are more likely to skip taking their meds, a new study finds.

Teens Think Smoking More Dangerous Than Drinking, Drugs
December 17, 2009
American teens believe that smoking cigarettes is riskier than using illicit drugs or binge drinking, a new government report shows.

Large Recall of Children's Swine Flu Vaccine
December 15, 2009
Almost 800,000 children's doses of H1N1 swine flu vaccine have been recalled by manufacturer Sanofi Pasteur Inc.

Antidepressants May Raise Women's Stroke Risk
December 14, 2009
Older women who take antidepressants may have a small but statistically significant increased risk of stroke and death compared to women not on the medications, a new study finds.

Marijuana Use No Longer Dropping Among U.S. Teens
December 14, 2009
Fewer teenagers are using methamphetamine, but reductions in marijuana use have stalled and abuse of prescription drugs remains high, United States health officials report.

'Nanosensors' Spot Early Signs of Cancer
December 13, 2009
Miniature "nanosensors" can detect early signs of cancer in everyday blood samples taken from patients, researchers report.

Better Vaccine Planning Needed, Committee Finds
December 11, 2009
More money and better coordination are needed to develop vaccines for serious illnesses for which no vaccinations currently exist, a new report says.

Poorer Neighborhoods May Bring Worse Health
December 11, 2009
Americans who live in poor neighborhoods are more likely to have health problems and to die prematurely, regardless of their dietary and lifestyle risk factors, according to a new study.

Bone Drugs May Beat Back Breast Cancer
December 10, 2009
Bone-building drugs used by tens of millions of women to fight osteoporosis also cut the risk of breast cancer, suggesting the drugs may play a dual role in keeping women healthy.

Most Hospital Patients Don't Know What Meds They're Taking
December 10, 2009
A small study finds that even adults who know what medicines they take at home can't accurately name the drugs they're getting in the hospital.

Addiction Meds May Help Gamblers
December 10, 2009
Drugs used to treat substance addictions could prove effective in treating pathological gambling, United States researchers say.

States Slash Funding for Tobacco Prevention Programs
December 9, 2009
States cut funding for tobacco prevention programs by more than 15 percent in the past year, even though they're receiving record amounts of money from tobacco taxes and from the 1998 state tobacco settlement, says a new report.

Seasonal Flu Vaccination Rates Still Too Low
December 9, 2009
Although the H1N1 pandemic flu has raised public awareness of the flu in general, there has been only a slight increase in the number of people choosing to get a seasonal flu shot, a new report shows.

Caffeine Doesn't Sober You Up
December 9, 2009
Downing a cup or two of coffee after a few belts of liquor won't sober you up enough to get you safely behind the wheel of a car, new research concludes.

A Good Year in the Fight Against AIDS
December 1, 2009
While the war against HIV/AIDS is still far from over, 2009 could prove to be a watershed year in terms of advances in prevention and treatment, experts say.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

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