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Vol 51 - November 2008
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Featured News

Study Calls for Greater Scrutiny of 'Off-Label' Drug Use

November 24, 2008
It's called "off-label" prescribing, and it's the common practice of doctors prescribing a drug to treat a disease or condition that's different from the one studied by federal regulators that led to the drug's approval in the first place. Despite the scope of the practice, there's often little evidence that using a drug for an unapproved purpose is always beneficial or safe, a new study found.
Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Promacta (eltrombopag) Tablets
Date of Approval: November 20, 2008
Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura
Promacta Drug Information | Press Release

Banzel (rufinamide) Tablets
Date of Approval: November 14, 2008
Treatment for: Lennox-Gastaut Syndrome
Banzel Drug Information | Press Release

Apriso (mesalamine) Extended-Release Capsules
Date of Approval: October 31, 2008
Treatment for: Ulcerative Colitis
Apriso Drug Information | Press Release

Toviaz (fesoterodine fumarate) Extended Release Tablets
Date of Approval: October 31, 2008
Treatment for: Overactive Bladder
Toviaz Drug Information | Press Release

Vimpat (lacosamide) Tablets and Injection
Date of Approval: October 28, 2008
Treatment for: Seizures
Vimpat Drug Information | Press Release

LoSeasonique (ethinyl estradiol and levonorgestrel) Extended-Cycle Oral Contraceptive Tablets
Date of Approval: October 24, 2008
Treatment for: Birth Control
LoSeasonique Drug Information | Press Release

Acanya (benzoyl peroxide and clindamycin phosphate) Topical Gel
Date of Approval: October 21, 2008
Treatment for: Acne
Acanya 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.

Premarin Vaginal Cream (conjugated estrogens)
New Indication Approved: November 7, 2008
Treatment for: Postmenopausal Dyspareunia
Premarin Vaginal Cream Drug Information | Press Release

Crestor (rosuvastatin calcium) Tablets
New Indication Approved: November 6, 2008
Treatment for: Primary Dysbetalipoproteinemia
Crestor Drug Information | Press Release

Ranexa (ranolazine)
New Indication Approved: November 5, 2008
Treatment for: First Line Treatment of Angina
Ranexa Drug Information | Press Release

Treanda (bendamustine hydrochloride) Injection
New Indication Approved: October 31, 2008
Treatment for: Relapsed Indolent Non-Hodgkin's Lymphoma
Treanda Drug Information | Press Release

Apidra (insulin glulisine) Injection
Patient Population Altered: October 24, 2008
Treatment for: Children with Diabetes
Apidra 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.

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
2% (base)/0.5% (base)
Approved: October 28, 2008 Hi-Tech Pharmacal Co., Inc.; Apotex Inc.
Generic for: Cosopt Ophthalmic Solution

Dorzolamide Hydrochloride Ophthalmic Solution
0.2% (base)
Approved: October 28, 2008 Apotex Inc.; Hi-Tech Pharmacal Company, Inc.
Generic for: Trusopt Ophthalmic Solution

Other Drug News

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

Steroid Inhalers Raise Pneumonia Risk for Lung Disease Patients
November 25, 2008
A new review of existing data confirms that some common inhalers don't boost the life spans of people with the lung disease known as chronic obstructive pulmonary disease (COPD).

A Third of Medicare Clients Unfamiliar With Benefits
November 25, 2008
How well a person on Medicare understands the program's benefits affects their access to health care, a new study says.

New Migraine Drug Shows Promise
November 24, 2008
A drug called telcagepant proved safe and effective in treating migraines and caused fewer side effects than the widely-used migraine drug zolmitriptan (Zomig), according to a study conducted by drug maker Merck & Co.

5 Million People a Year Use Self-Help Addiction Programs
November 24, 2008
An estimated five million Americans over the age of 12 participate in self-help groups for alcohol and drug abuse each year, including 2.3 million who currently abstain from use of these substance.

FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
November 21, 2008
Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD), announced that the U.S. Food and Drug Administration (FDA) has approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years of age or older.

Ginkgo No Shield Against Alzheimer's
November 18, 2008
Although commonly taken to improve memory, new research suggests that the herb ginkgo biloba won't help prevent dementia, including Alzheimer's disease.

FDA Takes Closer Look at Wrinkle Treatments
November 18, 2008
U.S. health advisers have been taking a closer look at those increasingly popular cosmetic treatments called dermal fillers that help to smooth away deep lines and wrinkles on the face.

Over 60 Million U.S. Adults Engaging in Health 2.0
November 3, 2008
Over 60 million U.S. adults are Health 2.0 consumers – reporting to use health blogs, online support groups, prescription rating sites, and other health-related social media applications, according to pharmaceutical and healthcare market research company Manhattan Research’s just released Cybercitizen Health v8.0 consumer study and strategic advisory service. The number of Health 2.0 consumers has doubled over the past year. The study also found that a consumer’s condition, as opposed to just age or gender, is an important factor in his or her likeliness to engage in health-related social media.

More News Headlines

FDA MedWatch Alerts

Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics)

Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel; Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication; Equate: Medicated Acne Gel

Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)

Update on Early Communication: Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D); Etidronate (Didronel); Ibandronate (Boniva); Pamidronate (Aredia); Risedronate (Actonel, Actonel W/Calcium); Tiludronate (Skelid); Zoledronic acid (Reclast, Zometa)

Propafenone HCl Tablets (150 mg, 225 mg, 300 mg), Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg), Morphine Sulfate Extended Release Tablets (15 mg), Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg), Dextroamphetamine Sulfate Tablets (10 mg)

ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)

More FDA Medwatch Alerts

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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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