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Vol 61 - September 2009
Featured News

Could the Recession Be Good for Your Health?

September 2009
The economic downturn may not be all bad - in fact, researchers say recessions may actually be good for health. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Stelara (ustekinumab) Injection
Date of Approval: September 25, 2009
Treatment for: Psoriasis
Stelara Drug Information | Press Release

Folotyn (pralatrexate) Injection
Date of Approval: September 24, 2009
Treatment for: Peripheral T-cell Lymphoma
Folotyn Drug Information | Press Release

Valturna (aliskiren and valsartan) Tablets
Date of Approval: September 16, 2009
Treatment for: Hypertension
Valturna Drug Information | Press Release

Influenza A (H1N1) 2009 Monovalent Vaccine
Date of Approval: September 15, 2009
Treatment for: Prevention of H1N1 Influenza
Influenza A (H1N1) 2009 Monovalent Vaccine Drug Information | Press Release

Zirgan (ganciclovir) Ophthalmic Gel
Date of Approval: September 15, 2009
Treatment for: Herpetic Keratitis
Zirgan Drug Information | Press Release

Vibativ (telavancin) Injection
Date of Approval: September 11, 2009
Treatment for: Complicated Skin and Skin Structure Infections (cSSSI)
Vibativ Drug Information | Press Release

Bepreve (bepotastine) Ophthalmic Solution
Date of Approval: September 8, 2009
Treatment for: Allergic Conjunctivitis
Bepreve Drug Information | Press Release

Metozolv ODT (metoclopramide) Orally Disintegrating Tablets
Date of Approval: September 4, 2009
Treatment for: Gastroesophageal Reflux Disease, Gastroparesis
Metozolv ODT Drug Information | Press Release

Intuniv (guanfacine) Extended Release Tablets
Date of Approval: September 2, 2009
Treatment for: Attention-Deficit Hyperactivity Disorder
Intuniv 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.

Astepro (azelastine) Nasal Spray
New Formulation Approved: August 31, 2009
Now Approved: Astepro Once-Daily
Astepro Drug Information | Press Release

Zevalin (ibritumomab tiuxetan) Injection
New Indication Approved: September 3, 2009
Now Approved for: Previously Untreated Follicular non-Hodgkin's Lymphoma
Zevalin 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.

Azelastine Hydrochloride Ophthalmic Solution
0.05%
Approved: August 3, 2009 Apotex Inc.
Generic for: Optivar Ophthalmic Solution

Oxaliplatin Injection
5 mg/mL; (preservative-free), packaged in 50 mg/10 mL and 100 mg/20 mL single-use vials
Approved: August 7, 2009 Hospira Worldwide; Sun Pharma Global; Fresenius Kabi Oncology
Generic for: Eloxatin Injection

Tacrolimus Capsules
0.5 mg, 1 mg and 5 mg
Approved: August 10, 2009 Sandoz, Inc.
Generic for: Prograf Capsules

Clindamycin Phosphate and Benzoyl Peroxide Gel
1% (base)/5%
Approved: August 11, 2009 Dow Pharmaceutical Sciences, Inc.
Generic for: Benzaclin Topical Gel

Aspirin and Dipyridamole Extended-Release Capsules
25 mg/200 mg
Approved: August 14, 2009 Barr Laboratories, Inc.
Generic for: Aggrenox Extended-Release Capsules

Clonidine Transdermal System
USP 0.1 mg/day, 0.2 mg/day and 0.3 mg/day
Approved: August 18, 2009 Aveva Drug Delivery Systems, Inc.
Generic for: Catapres-TTS

Levonorgestrel Tablets
(Rx/OTC) 0.75 mg
Approved: August 28, 2009 Watson Laboratories, Inc.
Generic for: Plan B Tablets

Other Drug News

Many Kids Suffer Medication Side Effects: Study
September 28, 2009
More than half a million kids a year are treated for medication side effects in American outpatient clinics and emergency rooms, according to new data.

Experimental AIDS Vaccine Delivers Good News
September 24, 2009
In an apparent milestone advance, an experimental AIDS vaccine tested on more than 16,000 young adult volunteers in Thailand cut the risk of infection by a third, researchers reported Thursday.

Injectable Vaccines More Effective for Adult Flu Than Nasal Sprays
September 23, 2009
If you have the choice between a seasonal flu vaccine that comes in a nasal spray or an injection, go for the injection, new research shows.

Cost Savings Adds to Value of Preventing Chronic Disease
September 23, 2009
Prevention of chronic diseases such as diabetes, obesity and high blood pressure improves the lives of older Americans and also reduces medical costs, study findings show.

Study Suggests a Wider Use for Statins
September 22, 2009
Statins could be as beneficial for people with acceptable cholesterol readings but high levels of inflammation as they are for those with high cholesterol levels, a new analysis finds.

Flavored Cigarette Ban Takes Effect
September 22, 2009
Young people who enjoy a hint of vanilla, berry or chocolate when they light up are about to have their favorite smokes snuffed out.

Could Swine Flu Panic Be Worse Than Outbreak Itself?
September 22, 2009
With all the warnings and preparations, dire predictions and hastily ordered vaccines, could the growing worry about H1N1 swine flu prove more disruptive than the actual outbreak? That notion is weighing on the minds of more than a few infectious-disease experts as the fall and winter flu season looms.

Progress Made Toward Vaccine for Urinary Infections
September 18, 2009
A vaccine to prevent urinary tract infections shows early promise in tests on mice, according to University of Michigan researchers.

More Teens Getting Needed Vaccines
September 17, 2009
While vaccination rates for adolescents in the United States are gaining ground, there is still a long way to go to meet Healthy People 2010 goals of 90 percent coverage, a new government report shows.

More News Headlines

FDA MedWatch Alerts

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