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Vol 63 - November 2009
Featured News

Diabetes Cases Expected to Double in 25 Years

November 2009
The number of people with diabetes in the United States is expected to double over the next 25 years, a new study predicts. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Qutenza (capsaicin) Transdermal Patch
Date of Approval: November 16, 2009
Treatment for: Postherpetic Neuralgia
Qutenza Drug Information | Press Release

Lysteda (tranexamic acid) Tablets
Date of Approval: November 13, 2009
Treatment for: Menorrhagia
Lysteda Drug Information | Press Release

Istodax (romidepsin) for Injection
Date of Approval: November 5, 2009
Treatment for: Cutaneous T-cell Lymphoma
Istodax Drug Information | Press Release

Pennsaid (diclofenac sodium) Topical Solution
Date of Approval: November 4, 2009
Treatment for: Osteoarthritis
Pennsaid 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.

Revatio (sildenafil citrate)
New Dosage Form Approved: November 18, 2009
Now Approved: Revatio Injection
Revatio Drug Information | Press Release

Abilify (aripiprazole)
New Indication Approved: November 19, 2009
Now Approved for: Irritability Associated with Autistic Disorder in Pediatric Patients
Abilify Drug Information | Press Release

Byetta (exenatide) Injection
New Indication Approved: November 2, 2009
Now Approved for: Type 2 Diabetes Monotherapy
Byetta Drug Information | Press Release

Influenza A (H1N1) 2009 Monovalent Vaccine
Patient Population Altered: November 10, 2009
Now Approved for: Childen 6 Months and Older
Influenza A (H1N1) 2009 Monovalent Vaccine 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.

Buprenorphine Hydrochloride
Sublingual Tablets 2 mg (base) and 8 mg (base)
Approved: October 8, 2009 Roxane Laboratories, Inc.
Generic for: Subutex

Chlorothiazide Sodium
for Injection, USP 500 mg (base)/vial
Approved: October 16, 2009 APP Pharmaceuticals, Inc.
Generic for: Diuril for Injection

Other Drug News

Implantable Cancer Vaccine Shows Promise
November 25, 2009
A cancer vaccine delivered in a fingernail-size implant eliminated melanoma tumors in mice, a new study reports.

One Step Closer to New Diabetes Treatment
November 25, 2009
Mitochondrial damage causes people with type 2 diabetes to lose insulin-producing cells, a finding that could lead to new treatments, researchers say.

Some Prescription Meds May Raise Seniors' Risks of Falling
November 24, 2009
Seniors who take antidepressants, sedatives and other psychotropic medications may be at increased risk for falls, a new review shows.

Ginkgo Won't Prevent Heart Attack, Stroke in Elderly
November 24, 2009
Among people aged 75 and older, the herbal supplement Ginkgo biloba does not prevent heart attacks, stroke or death, a new study finds.

Sleep Disorders Plague Cancer Patients
November 23, 2009
Insomnia and sleep disorders affect more than three-quarters of cancer patients undergoing chemotherapy, a rate nearly three times higher than that of the general population, a new study finds.

Vioxx Problems Known Years Before Recall
November 23, 2009
Problems with the popular arthritis drug Vioxx, including increased risk for heart attack, stroke and death, were known for years before the drug's voluntary withdrawal from the market in 2004, a new report says.

Three-Month Supply Lowers Drug Costs
November 20, 2009
Buying a three-month supply of prescription drugs is up to one-third cheaper than buying a one-month supply, according to a new study.

WHO: Swine Flu Shot Not Causing Deaths
November 19, 2009
The World Health Organization has ruled out swine flu vaccine as the cause of death in 41 people who had received the flu shot.

Vaccines on Horizon for AIDS, Alzheimer's, Herpes
November 18, 2009
You name it, the pharmaceutical industry is working on a vaccine to prevent it.

Heartburn Drugs Can Thwart Popular Blood Thinner
November 17, 2009
Combining the antacid Prilosec with the popular blood thinner Plavix (clopidogrel) can cut the effectiveness of Plavix by half, putting patients at risk for heart attack or stroke, according to health officials.

Sharing Prescriptions Can Bring Harm, Not Healing
November 11, 2009
Sharing prescription medication with a family member or friend who needs care may seem like the right thing to do, even an act of kindness.

FDA Initiative Seeks to Reduce Accidental Overdoses
November 4, 2009
U.S. health authorities have unveiled an initiative designed to reduce preventable injuries and deaths caused by misuse of medications.

Nicotine Patch Plus Lozenge Best for Quitting Smoking
November 2, 2009
The first head-to-head comparison of different quit-smoking products finds that a nicotine patch combined with a nicotine lozenge had the most success.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

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