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Newsletter
Vol 86 - October 2011
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 28, 2011
Treatment for: Pain
Exparel Drug Information | Press Release
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.
Key to Label Sections:
BW - Boxed Warning C - Contraindications
W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert
MG - Medication Guide PCI - Patient Counseling Information

  Sections Modified
Drug Name BW C W P AR PPI MG PCI
Detrol
(tolterodine tartrate) tablets and Detrol LA (tolterodine tartrate) extended release tablets
- x x - x x - -
Orap
(pimozide) 1 mg and 2 mg tablets
- x - x - - - -
Anzemet
(dolasetron mesylate) tablets and Anzemet (dolasetron mesylate) injection
- - x - - - - -
Atripla
(efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets
- - x x x - - -
Avastin
(bevacizumab)
- - x x x - - -
Cymbalta
(duloxetine hydrochloride) capsules
- - x x - - - -
Effient
(prasugrel hydrochloride) 5 mg and 10 mg Tablets
- - x x - - - -
Ellence
(epirubicin hydrochloride) injection
- - x - - - - -
Istodax
(romidepsin) for Injection
- - x x - - - -
MultiHance
(gadobenate dimeglumine) injection
- - x x - - - -
Nicorette
(nicotine polacrilex) 2 mg and 4mg gum [OTC]
- - x - - - - -
Procardia
(nifedipine) 10 mg Capsules
- - x - x - - -
Procardia XL
(nifedipine) 30 mg, 60 mg, and 90 mg Extended Release Capsules
- - x - x - - -
Risperdal
(risperidone) tablets, oral solutionRisperdal M-Tab (risperidone) orally disintegrating tabletsRisperdal Consta (risperidone) long-acting injection
- - x x - - - -
Stimate
(desmopressin acetate) 1.5 mg/mL nasal spray
- - x - - - - -
Sustenna
(paliperidone palmitate) Extended-Release Injectable Suspension for intramuscular use
- - x x - - - -
Xenon Xe 133 Gas, 10 and 20 mCi, septum sealed glass vial
- - x - - - - -
Zofran
(ondansetron hydrochloride) injection and premixed injection
- - x - - - - -
Zofran
(ondansetron hydrochloride) tablets, oral solution, and orally disintegrating tablets
- - x - - - - -
Claforan
(cefotaxime sodium) Injection
- - - x - - - -
Mavik
(trandolapril) 1 mg, 2 mg and 4 mg Tablets
- - - x - - - -
Sanctura
(trospium chloride) and Sanctura XR (trospium chloride extended release)
- - - x - - - -
Sustiva
(efavirenz) Tablets and Capsules
- - - x - - - -
Tarka
(trandolapril/verapamil hydrochloride) tablets
- - - x - - - -
Aldactazide
(spironolactone/hydrochlorothiazide) tablets
- - - - x - - -
Aldactone
(spironolactone) tablets
- - - - x - - -
Fosrenol
(lanthanum carbonate) 500 mg, 750 mg, and 1000 mg Chewable Tablets
- - - - x - - -
Latisse
(bimatoprost) ophthalmic solution
- - - - x - - -
Lexiscan
(regadenoson) injection
- - - - x - - -
Travatan
(travoprost) and Travatan Z (travoprost)
- - - - x - - -
Vyvanse
(lisdexamfetamine dimesylate)
- - - - x - - -
Doxorubicin
(doxorubicin hydrochloride) for injection
- - - - - x - -
Noroxin
(norfloxacin) tablets
- - - - - - - -
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.
FDA MedWatch Alerts
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