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Vol 87 - November 2011
Featured News
Monthly Roundup - November 2011
November 2011
Intermezzo Approved for Middle of Night Insomnia Intermezzo (zolpidem tartrate), a low-dose, sublingual form of zolpidem tartrate, was FDA-approved for insomnia associated with middle-of-the night awakenings. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: November 23, 2011
Treatment for: Insomnia
Intermezzo Drug Information | Press Release
Date of Approval: November 18, 2011
Treatment for: Acute Lymphoblastic Leukemia
Erwinaze Drug Information | Press Release
Date of Approval: November 18, 2011
Treatment for: Macular Degeneration
Eylea Drug Information | Press Release
Date of Approval: November 16, 2011
Treatment for: Myelofibrosis
Jakafi 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 Indication Approved: November 4, 2011
Now Approved for: Prevention of Thromboembolism in Atrial Fibrillation
Xarelto Drug Information | Press Release
New Indication Approved: November 7, 2011
Now Approved for: Late-Stage Head and Neck Cancer
Erbitux 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.
Fluocinolone Acetonide Otic Oil
Approved: October 17, 2011 - Identi Pharmaceuticals Inc.
Generic for: DermOtic Oil
Fluocinolone Acetonide Topical Oil
Approved: October 17, 2011 - Identi Pharmaceuticals Inc.
Generic for: Derma-Smoothe/FS Scalp Oil
Fluocinolone Acetonide Topical Oil
Approved: October 17, 2011 - Identi Pharmaceuticals Inc.
Generic for: Derma-Smoothe/FS Body Oil
Olanzapine Tablets
2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg
Approved: October 24, 2011 - Teva Pharmaceuticals USA
Generic for: Zyprexa
Olanzapine Tablets
20 mg
Approved: October 24, 2011 - Dr. Reddy's Laboratories Ltd.
Generic for: Zyprexa
Olanzapine Intramuscular Injection
10 mg/vial
Approved: October 24, 2011 - InnoPharma LLC
Generic for: Zyprexa Injection
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for October 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
Definity Vial for
(Perflutren Lipid Microsphere) Injectable Suspension
x - x x x - - -
(estradiol transdermal spray)
x - x x - x - -
(maraviroc) Tablets
x - x x - - - -
(meperidine hydrochloride)
- x - x - - - -
(topotecan) Capsules
- x x x x - - -
(conjugated estrogens tablets, USP)
- x x - - x - -
(phentermine hydrochloride) ODT
- x - - - - - -
(amlodipine/aliskiren/hydrochlorothiazide) Tablets
- - x x x - - -
(moxifloxacin hydrochloride) Tablets and IV
- - x x - - - -
(exenatide) injection
- - x x x - - -
(clozapine) Tablets
- - x x - - - -
Ciprofloxacin Tablets Ciprofloxacin IV for Inusion Vial Ciprofloxacin 0.2 % Solution in 5% Dextrose Ciprofloxacin Oral Suspension Cipro XR Tablets
- - x - - - - -
(gemifloxacin mesylate) Tablets
- - x - - - - -
Gallium Citrate Ga 67 Injection
- - x - - - - -
Sodium Lactate
(M/6 sodium lactate) injections in viaflex plastic container
- - x x x - - -
(levofloxacin) Tablets
- - x x - - - -
Lithium Carbonate 150 mg, 300 mg, and 600 mg capsules
- - x - x - - -
(lithium carbonate) Extended-Release tablets
- - x - x - - -
- - x x x - - -
(norfloxacin) Tablets
- - x - - - - -
(oxycodone hydrochloride) Controlled-Release Tablets
- - x x - - - -
(nilotinib) Capsules
- - x x - - - -
(fluticasone furoate) Nasal Spray
- - x x x - - -
(pazopanib hydrochloride) Tablets
- - x x x - - -
(teniposide) Injection
- - x - x - - -
(ezetimibe/simvastatin) Tablets
- - x x x - - -
(simvastatin) Tablets
- - x x - - - -
(quinapril hydrochloride) Tablets
- - - x - - - -
(quinapril HCl/hydrochlorothiazide)
- - - x - - - -
(amlodipine and olmesartan medoxomil) Tablets
- - - x - - - -
(dexlansoprazole) delayed-release capsules
- - - x - - - -
(amlodipine/valsartan) Tablets
- - - x - - - -
Exforge HCT
(amlodipine/valsartan/hydrochlorothiazide) Tablets
- - - x - - - -
(etravirine) Tablets
- - - x - x - -
Ixempra kit
(ixabepilone) for injection
- - - x - - - -
(chlorambucil) Tablet
- - - x - - - -
(amlodipine besylate and benazepril hydrochloride) Capsules
- - - x - - - -
(pegaptanib sodium injection)
- - - x - - - -
(amlodipine besylate) Tablets
- - - x - - - -
(lansoprazole) Delayed-Release Capsules and Prevacid Solutab (lansoprazole) Delayed-Release Orally Disintegrating Tablets
- - - x - - - -
(pantoprazole sodium) For Delayed Release Oral Suspension and Delayed Release Tablets
- - - x - - - -
(aliskiren) Tablets
- - - x - - - -
(darunavir) Tablets
- - - - x x - -
(atazanavir sulfate)
- - - - x - - -
(asenapine) sublingual Tablets
- - - - x - - -
(dasatinib) Tablets
- - - - x - - -
(olanzapine and fluoxetine HCl)
- - - - x - - -
Humalog Mix 75/25
(75% insulin lispro protamine suspension/25% insulin lispro injection [rDNA origin]) Humalog Mix 50/50 (50% insulin lispro protamine suspension/50 insulin lispro injection [rDNA origin])
- - - - - x - -
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
Newer Blood Thinner May Pose Danger to Trauma Patients
November 23, 2011
A new blood thinner touted for its convenience and enhanced quality of life may have hidden problems that could threaten the lives of certain patients, a new report suggests.
Four Common Meds Send Thousands of Seniors to Hospital: CDC
November 23, 2011
An estimated 100,000 older Americans are hospitalized for adverse drug reactions yearly, and most of those emergencies stem from four common medications, a new study finds.
Cholesterol-Lowering Drugs Safe for Long-Term Use, Study Finds
November 22, 2011
British researchers have good news for anyone taking the cholesterol-lowering medications known as statins: These drugs are effective and safe, even when used for long periods of time, they say.
Too Much Acetaminophen Over Time May Damage Liver
November 22, 2011
Taking slightly too much of the pain reliever acetaminophen (best known by the brand name Tylenol) over time can lead to an overdose that can cause liver failure and death, according to a new study.
Cholesterol Drug Shows Promise in Early Research
November 15, 2011
Preliminary trials indicate that a new drug designed to simultaneously boost good cholesterol while lowering bad cholesterol shows considerable promise, both on its own and in combination with standard statin medications.
Could Women's Use of 'the Pill' Raise Men's Prostate Cancer Risk?
November 14, 2011
With the vast increase in the use of the contraceptive pill over the past 40 years, the amount of estrogen entering the water supply may be partly responsible for the increased incidence of prostate cancer around the world, Canadian researchers speculate.
Experimental Drug for Irregular Heart Rhythm Raises Death Risk: Study
November 14, 2011
A once-promising drug for a common and dangerous form of irregular heart rhythm actually seems to raise the odds for patient death, a new study finds.
More Teens Getting Vaccines Against HPV, Other Infections: CDC
November 14, 2011
Although the number of teens getting three new recommended vaccines is growing, there's still room for improvement, government researchers report.
Shot Might One Day Help Lower Cholesterol
November 14, 2011
Preliminary research suggests that a single injection of a man-made protein might lower levels of "bad" cholesterol.
Blood Thinner Xarelto Shows Promise for Heart Patients
November 13, 2011
When added to standard treatment, a new blood-thinning drug called Xarelto (rivaroxaban) may help people with "acute coronary syndrome" lower their risk of death, subsequent heart attack or stroke, a new study finds.
New Treatment May Boost Survival in Advanced Lung Cancer Cases
November 9, 2011
For the first time, "epigenetic" therapy has shown promise in patients with solid tumors, in this case non-small cell lung cancers.
More Evidence That HPV Vaccine Shields Against Cervical Cancer
November 9, 2011
A new study suggests that the Cervarix cervical cancer vaccine may provide "excellent" protection against a precancerous lesion that is often a forerunner to invasive cervical cancer.
Vaccine to Treat Breast, Ovarian Cancers Shows Promise
November 8, 2011
A vaccine that coaxes the body to attack tumor cells has shown promise in a small study of advanced breast and ovarian cancer patients, improving overall survival times and stopping the disease for a handful of breast cancer patients.
New Drug Shows Promise Against Huntington's Disease
November 7, 2011
An investigational drug called pridopidine seems an effective and safe treatment for people with the progressive movement disorder Huntington's disease, researchers report.
More People Landing in the ER After Abusing Muscle Relaxant: Report
November 3, 2011
The number of people winding up in the emergency room because of the misuse or abuse of the prescription muscle relaxant carisoprodol has more than doubled, a new federal report warns.
Too Many Meds May Be More Problem Than Cure
November 3, 2011
Barely a week goes by, it seems, without some company announcing a new pill designed to help you live a longer, healthier life.
New Drug Targets Underlying Cause of Cystic Fibrosis
November 2, 2011
A new drug that targets a faulty protein that causes cystic fibrosis led to improved lung function and fewer symptoms in people with the lung disease, researchers report.
FDA MedWatch Alerts
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