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Vol 45 - May 2008
Think You Can't Afford Quality Health Insurance?
Featured News

Chronic Medication Nation: Research Finds Chronic Health Problems Now Afflict More Than Half of All Americans

May 14, 2008
Americans have tipped the scale. For the first time, a majority of the insured population is being treated for a chronic medical condition, raising serious concerns about the health of the nation. Research released today by Medco Health Solutions, Inc. shows that in 2007, 51 percent of insured Americans were taking prescription drugs to treat at least one chronic health problem. Not only is it now a majority, but many of these patients are on multiple medications. According to the analysis, one fifth of the population used three or more of these chronic drug treatments last year.
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New Drug Approvals

The following drugs have recently been approved by the FDA.

OraVerse (phentolamine mesylate) Injection
Date of Approval: May 9, 2008
Treatment for: Reversal of Dental Anesthesia
OraVerse Drug Information | Press Release

Relistor (methylnaltrexone bromide) Subcutaneous Injection
Date of Approval: April 25, 2008
Treatment for: Opioid-Induced Constipation
Relistor Drug Information | Press Release

Aplenzin (bupropion hydrobromide) Extended-Release Tablets
Date of Approval: April 23, 2008
Treatment for: Depression
Aplenzin Drug Information | Press Release

Cimzia (certolizumab pegol) Injection
Date of Approval: April 22, 2008
Treatment for: Crohn's Disease
Cimzia 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.

Seroquel (quetiapine) Tablets
New Indication Approved: May 13, 2008
Treatment for: Maintenance Treatment in Bipolar Disorder
Seroquel Drug Information | Press Release

NovoSeven RT (coagulation factor VIIa [recombinant]) Injection
New Formulation Approved: May 9, 2008
Treatment for: Room Temperature Stable Formulation for Hemophilia Patients With Inhibitors
NovoSeven Drug Information | Press Release

Taclonex Scalp (betamethasone and calcipotriene) Topical Suspension
New Formulation Approved: May 9, 2008
Treatment for: Scalp Psoriasis
Taclonex Scalp Drug Information | Press Release

Abilify (aripiprazole)
New Indication Approved: May 6, 2008
Treatment for: Add-On Treatment of Bipolar I Disorder
Abilify Drug Information | Press Release

Abilify (aripiprazole)
New Dosage Regimen Approved: May 6, 2008
Treatment for: Bipolar I Disorder in Pediatric Patients 10-17 years and Schizophrenia in Adolescents 13-17 years
Abilify Drug Information | Press Release

Strattera (atomoxetine) Capsules
New Indication Approved: May 7, 2008
Treatment for: Maintenance of ADHD in Children and Adolescents
Strattera Drug Information | Press Release

Advair Diskus 250/50 (fluticasone and salmeterol) Inhalation Powder
New Indication Approved: April 30, 2008
Treatment for: Reduction of Exacerbations in Patients With COPD
Advair Diskus Drug Information | Press Release

Amitiza (lubiprostone) Capsules
New Indication Approved: April 29, 2008
Treatment for: Irritable Bowel Syndrome with Constipation in Adult Women
Amitiza Drug Information | Press Release

Actonel (risedronate) Tablets
New Dosage Regimen Approved: April 22, 2008
Treatment for: Once-a-Month Dose for Postmenopausal Osteoporosis
Actonel Drug Information | Press Release

Vyvanse (lisdexamfetamine) Capsules
Patient Population Altered: April 23, 2008
Treatment for: ADHD in Adults
Vyvanse 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.

Cetirizine Hydrochloride Oral Solution
1 mg/mL (OTC)
Approved: April 9, 2008 Perrigo R&D Company
Generic for: Children's Zyrtec Allergy And Hives-Relief

Levalbuterol Hydrochloride Inhalation Solution
0.31 mg (base), 0.63 mg (base), and 1.25 mg (base); packaged in 3 mL Unit-Dose Vials
Approved: April 9, 2008 Breath Limited
Generic for: Xopenex Inhalation Solution

Fluorouracil Cream
USP, 5%
Approved: April 11, 2008 Spear Pharmaceuticals, Inc.
Generic for: Efudex Topical Cream, 5%

Estradiol And Norethindrone Acetate Tablets
1 mg/0.5 mg
Approved: April 17, 2008 Breckenridge Pharmaceutical, Inc.
Generic for: Activella Tablets

Ribavirin Tablets
500 mg (New Strength)
Approved: April 18, 2008 Zydus Pharmaceuticals USA, Inc.
Generic for: Copegus Tablets

Epoprostenol Sodium for Injection
0.5 Mg (base)/vial and 1.5 mg (base)/vial
Approved: April 23, 2008 Teva Parenteral Medicines, Inc.
Generic for: Flolan for Injection

Donepezil Hydrochloride Tablets
5 mg and 10 mg
Approved: April 28, 2008 Teva Pharmaceuticals USA
Generic for: Aricept Tablets

Other Drug News

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

Adolor and GlaxoSmithKline Announce FDA Approval of Entereg (alvimopan) for the Management of Postoperative Ileus (POI)
May 20, 2008
Adolor Corporation and GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved Entereg (alvimopan) capsules to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.

Global Menopause Summit Concludes HRT is Safe for Healthy Women Entering Menopause
May 20, 2008
HRT in the early postmenopausal period is safe, and healthy women going through the first few years of the menopause who need HRT to relieve symptoms should have no fears about its use. This is the conclusion and clinical advice of the First Global Summit on Menopause-Related Issues, which was held in Zürich on March 29th and 30th, 2008.

Celebrex Shows Benefit In First-of-Its-Kind Lung Cancer Chemoprevention Trial
May 16, 2008
Celecoxib, the anti-inflammatory medication also known by the trade name Celebrex, has proven to be safe and reduces a specific proliferation measurement of precancerous lesions in the lung, according to a study from The University of Texas M. D. Anderson Cancer Center.

Diabetes Drugs Emerge as Top Force in Drug Spending Growth
May 15, 2008
Diabetes treatments are now the leading driver of prescription drug spending growth, displacing lipid-lowering drugs which fell precipitously after a decade of reigning in the top position, as generic drugs cut the cost of treating high cholesterol.

Manufacturer Removes Remaining Stocks of Trasylol
May 14, 2008
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock.

Hormone Therapy in Postmenopausal Women Associated with Increased Risk of Stroke
April 28, 2008
Postmenopausal women taking hormone therapy appear to have an increased risk of stroke regardless of when they started treatment, according to a report in the April 28 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

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