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Featured News Monthly Roundup - October 2011
October 2011
Non-Opioid Exparel Approved for Post-Surgical Pain Relief Exparel (bupivacaine liposome injectable suspension), a non-opioid local anesthetic agent, has received FDA-approval for post-surgical pain relief. Read more... New Drug Approvals
The following drugs have recently been approved by the FDA. Date of Approval: October 21, 2011 Treatment for: Lennox-Gastaut Syndrome Onfi Drug Information | Press Release Date of Approval: October 14, 2011 Treatment for: Hemosiderosis Ferriprox Drug Information | Press Release Date of Approval: October 7, 2011
Treatment for: Diabetes Mellitus Type II, Homozygous Familial Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia, Hypertriglyceridemia Juvisync 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. New Formulation Approved: October 7, 2011 Now Approved: Combivent Respimat Combivent Drug Information | Press Release New Indication Approved: October 7, 2011
Now Approved for: Benign Prostatic Hyperplasia Cialis 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.
Levetiracetam Extended-Release Tablets 500 mg and 750 mg Approved: September 12, 2011 - Actavis Elizabeth LLC; Par Pharmaceutical, Inc.; Apotex, Watson Laboratories, Inc.; Mutual Pharmaceutical Company, Inc.; Teva Pharmaceuticals USA Generic for: Keppra XR
Felbamate Tablets 400 mg and 600 mg Approved: September 13, 2011 - Amneal Pharmaceuticals Generic for: Felbatol Tablets
Doxercalciferol Capsules
0.5 mcg Approved: September 23, 2011 - Roxane Laboratories, Inc. Generic for: Hectorol Capsules FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for September 2011. Click on a drug name to view the changes in more detail.
Note: the drug safety labeling changes listed above may not be a complete list. Please visit the link below for the entire current list and historical archive.
Other Drug News
Experimental Psoriasis Drug Bests Older Treatment October 26, 2011 An experimental psoriasis treatment performed significantly better than the commonly prescribed medication methotrexate in a new clinical trial.
Newer 'Pill' May Raise Blood Clot Risk October 26, 2011 Birth control pills with newer types of progestogen hormones (drospirenone, desogestrel or gestodene) are more likely than others to cause serious blood clots, a new study confirms.
Some Asthma Drugs Raise Risk of Complications, Especially in Kids: Study October 25, 2011 When used alone, the asthma medications known as long-acting beta-agonists are associated with an increased risk of serious complications, new research indicates.
Taking Blood Pressure Meds at Bedtime May Be Better October 24, 2011 For the millions of Americans on blood pressure-lowering drugs, a new study suggests that taking the pills at bedtime may be best.
Experimental Vaccine Shows Promise for Lung Cancer: Study October 24, 2011 New research suggests that physicians may be able to strengthen the power of chemotherapy in patients with the most common form of lung cancer by adding a cancer vaccine to the treatment.
Femara May Beat Tamoxifen at Preventing Breast Cancer's Return October 21, 2011 The breast cancer drug letrozole, marketed as Femara, may be more effective than tamoxifen at preventing the return of breast cancer and improving survival among older women with hormone-sensitive breast cancers, a new study reports.
Antidepressant Use Skyrocketed in Past 20 Years: CDC October 19, 2011 The rate of antidepressant use among Americans of all ages increased nearly 400 percent over the last two decades, and 11 percent of Americans aged 12 and older now take antidepressant drugs, according to a federal government report.
Promising Malaria Vaccine May Save Children's Lives October 18, 2011 In an important first, a new vaccine has been shown to cut the risk of malaria in young African children by about half, according to research announced Tuesday.
Hormonal Treatment of Hot Flashes Still OK for Some: Experts October 18, 2011 Women do have options when it comes to treating hot flashes and other symptoms of menopause, and these still include the short-term use of hormone replacement therapy using estrogen alone, experts conclude in a new consensus report.
New ADHD Guidelines Include Preschoolers, Older Teens October 16, 2011 In new guidelines, the American Academy of Pediatrics has expanded the age range for the diagnosis and treatment of attention-deficit hyperactivity disorder (ADHD) to children as young as 4 and as old as 18.
Genetic Profiling Adds New Dimension to Breast Cancer Treatment October 14, 2011 Treatment for breast cancer has advanced in recent years by becoming more and more personalized.
New Alzheimer's Drug Shows Early Promise October 10, 2011 An experimental Alzheimer's disease drug, gantenerumab, may help lower levels of amyloid plaque in the brains of people with the disease, an early clinical trial indicates.
Drug Combo Might Fight Aggressive Breast Cancer More Safely October 5, 2011 Treating women with an aggressive form of early stage breast cancer using Herceptin and chemotherapy, while not turning to a third type of drug known as an anthracycline, improves survival while posing less danger to the heart, researchers report.
Experimental MS Drug Shows Promise October 5, 2011 A new oral drug for relapsing forms of multiple sclerosis appears to reduce relapse rates and disability progression, according to the results of a so-called phase 3 trial. |
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