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Newsletter
Vol 83 - July 2011
Featured News
Monthly Roundup - July 2011
July 2011
We know it's still summer, but don't forget: those flu shots are due to be renewed each fall. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: July 20, 2011
Treatment for: Acute Coronary Syndrome
Brilinta Drug Information | Press Release
Date of Approval: July 1, 2011
Treatment for: Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery
Xarelto Drug Information | Press Release
Date of Approval: July 1, 2011
Treatment for: Chronic Obstructive Pulmonary Disease
Arcapta Drug Information | Press Release
Date of Approval: June 30, 2011
Treatment for: Pain
Lazanda 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.
Labeling Revision Approved: July 14, 2011
Now Approved for: Maintenance of Remission of Ulcerative Colitis
Lialda Drug Information | Press Release
Labeling Revision Approved: July 18, 2011
Now Approved: Mixing Oral Suspension With Fruit Juice or Diet Soft Drinks
Welchol Drug Information | Press Release
New Dosage Form Approved: July 25, 2011
Now Approved: Subcutaneous Route of Administration
Gammagard Liquid Drug Information | Press Release
New Indication Approved: July 21, 2011
Now Approved for: Glabellar Lines
Xeomin Drug Information | Press Release
Patient Population Altered: July 8, 2011
Now Approved for: Seniors 65 and over
Boostrix 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.
Ethinyl Estradiol and Levonorgestrel Tablets
USP 0.02 mg/0.09 mg
Approved: June 6, 2011 - Watson Laboratories, Inc.
Generic for: Lybrel
Clobetasol Propionate Shampoo
0.05%
Approved: June 7, 2011 - Actavis Mid Atlantic, LLC
Generic for: Clobex Shampoo
Clobetasol Propionate Topical Solution
USP, (Spray) 0.05%
Approved: June 16, 2011 - Paddock Laboratories, Inc.
Generic for: Clobex Spray
Levofloxacin Injection
25 mg/mL; packaged in 500 mg/20 mL and 750 mg/30 mL Single-Use Vials
Approved: June 20, 2011 - Akorn, Inc.; Sagent Strides, LLC
Generic for: Levaquin Injection
Levofloxacin Tablets
250 mg, 500 mg and 750 mg
Approved: June 20, 2011 - Aurobindo Pharma Limited; Sandoz, Inc.; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA; Dr. Reddy's Laboratories Limited; Torrent Pharmaceuticals; Wockhardt Limited; Glenmark Generics Ltd.
Generic for: Levaquin Tablets
Levofloxacin Oral Solution
25 mg/mL
Approved: June 20, 2011 - Hi-Tech Pharmacal Co., Inc.
Generic for: Levaquin Oral Solution
Sumatriptan Succinate Injection
6 mg (base)/0.5 mL; packaged in a Single-Dose Syringe With Autoinjector
Approved: June 21, 2011 - Sun Pharma Global FZE
Generic for: Imitrex Statdose System
Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets
USP, (OTC) 180 mg/240 mg (24-Hour Formulation)
Approved: June 22, 2011 - Dr. Reddy's Laboratories Limited
Generic for: Allegra-D 24 Hour Extended-Release Tablets
Flucytosine Capsules
USP, 250 mg and 500 mg
Approved: June 28, 2011 - Sigmapharm Laboratories, LLC
Generic for: Ancobon
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for May 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
Imuran
(azathioprine) Tablets and Injection
x - x - x - - -
Biaxin Filmtab
(clarithromycin tablets, USP)Biaxin XL Filmtab (clarithromycin extended-release tablets)Biaxin Granules (clarithromycin for oral suspension, USP)
- x x - x - - -
Afinitor
(everolimus) Tablets
- - x x - - - -
Aldactazide
(spironolactone/hydrochlorothiazide) Tablets
- - x - - - - -
Avandia
(rosiglitazone maleate)Avandamet (rosiglitazone maleate/metformin hydrochloride)Avandaryl (rosiglitazone maleate/glimepiride) Tablets
- - x x - - - -
Benicar HCT
(olmesartan medoxomil/hydrochlorothiazide) Tablets
- - x - - - - -
Genotropin
(somatropin [rDNA origin] for Injection
- - x x x - - -
Humalog
(insulin lispro [rDNA origin]) Injection
- - x x - - - -
Levatol
(penbutolol sulfate) Tablets
- - x x - - - -
Micardis HCT
(telmisartan/hydrochlorothiazide) Tablets
- - x x - - - -
Norditropin Cartridges
(somatropin [rDNA origin] injection)
- - x x x - - -
Purinethol
(mercaptopurine) Tablets
- - x - - - - -
Seroquel XR
(quetiapine fumarate) Extended-Release
- - x x - - - -
Seroquel
(quetiapine fumarate) Tablets
- - x x - - - -
Sutent
(sunitinib malate) Capsules
- - x x x - - -
Teveten HCT
(eprosartan mesylate/hydrochlorothiazide) Tablets
- - x x - - - -
Uniretic
(moexipril hydrochloride/hydrochlorothiazide)
- - x - - - - -
Zegerid
(omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension
- - x x x - - -
Ziac
(bisoprolol fumarate/hydrochlorothiazide) Tablets
- - x - - - - -
Azor
(amlodipine and olmesartan medoxomil) Tablets
- - - x x - - -
Capoten
(captopril) Tablets
- - - x - - - -
Exforge
(amlodipine/valsartan) Tablets
- - - x - - - -
Lexiva
(fosamprenavir calcium) Tablets and Oral Suspension
- - - x - - - -
Teveten
(eprosartan mesylate) Tablets
- - - x - - - -
Valturna
(aliskiren/valsartan) Tablets
- - - x - - - -
Benicar
(olmesartan medoxomil) Tablets
- - - - x - - -
Vibramycin
(doxycycline monohydrate) Oral Suspension
- - - - x - - -
Vibra-Tabs
(doxycycline hyclate) 
- - - - x - - -
Foradil Aerolizer
(formoterol fumarate inhalation powder)
- - - - - - - -
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
McNeil Consumer Healthcare Announces Plans for New Dosing Instructions for Tylenol Products
July 28, 2011
McNeil Consumer Healthcare today announced plans for new dosing instructions lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the United States from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg).
Methamphetamine Abuse May Raise Parkinson's Risk
July 26, 2011
People who abuse methamphetamine or other stimulants are at increased risk for Parkinson's disease, a new study warns.
Antibiotics Beat Cranberries at Fighting Urinary Tract Infections in Study
July 25, 2011
Many women swear by cranberry juice or capsules for the treatment and prevention of urinary tract infections, but new Dutch research indicates that antibiotics may be more effective even if they contribute to a greater risk for antibiotic resistance.
CDC Issues Guidance for Coping With Lingering Heat
July 25, 2011
Residents still struggling with extreme hot weather in the Midwest, South and East Coast need to make sure they stay cool and hydrated to prevent heat illnesses and injuries such as heat exhaustion and heat stroke, federal health officials said Monday.
Chickenpox Vaccine May Wipe Out Related Deaths: Study
July 25, 2011
The varicella vaccine has nearly wiped out deaths from chickenpox in the United States, a new study shows.
Drug Prices to Plummet in Wave of Expiring Patents
July 25, 2011
The cost of prescription medicines used by millions of people every day is about to plummet.
Low 'Health Literacy' Hazardous to Your Health
July 22, 2011
If you have low "health literacy," defined as having difficulty understanding medical information, your health may be at risk.
Are Newer MS Drugs Worth Their High Price Tag?
July 21, 2011
Newer "biologic" drugs for multiple sclerosis do benefit some patients, a new study finds, but they are extraordinarily expensive and may not be cost-effective when compared to more basic treatments.
Experimental Drug Might Help Fight Alzheimer's After All
July 20, 2011
An experimental drug for treating Alzheimer's disease that previously showed troubling side effects may actually be safe in the long run, researchers report.
Stopping Daily Aspirin Boosts Heart Attack Risk: Study
July 19, 2011
People with heart disease who stop taking their daily low-dose aspirin may put themselves at a greater risk of having a heart attack, a new study finds.
U.S. Panel Recommends Free Coverage of Birth Control
July 19, 2011
Women in the United States could have their birth control covered by insurance companies, free of co-pays, if provisions of a new report are enacted as part of last year's landmark health-reform law.
Drug May Prevent Chemo-Linked Menopause in Breast Cancer Patients
July 19, 2011
Giving the ovaries a rest when young women with breast cancer are undergoing chemotherapy may help prevent early menopause and preserve fertility.
Two Antidepressants Given to Dementia Patients Ineffective: Study
July 19, 2011
The antidepressants most often prescribed to treat depression in dementia patients provide no appreciable relief, and may raise the risk for serious side effects, new British research suggests.
Statins Don't Seem to Raise Cancer Risk
July 18, 2011
A large, new study appears to quell concerns that taking statins might raise the risk of cancer.
FDA Unveils Flu Vaccines for 2011-12 Season
July 18, 2011
Influenza may be far from most Americans' thoughts as much of the nation wilts under oppressive heat, but the FDA has announced it is already preparing for the 2011-12 flu season.
More Evidence That Early Treatment Can Stop HIV's Spread to Partners
July 18, 2011
Researchers on Monday released yet more evidence that early treatment of HIV in an infected heterosexual can protect his or her partner from becoming infected.
Injection Drug Users Most in Need of Treatment, Study Says
July 15, 2011
Injection drug users have the greatest need for substance abuse treatment, regardless of what types of drugs they use, according to a new study.
Researchers Closer to Developing Universal Meningitis B Vaccine
July 15, 2011
New research may bring scientists one step closer to developing a vaccine that protects against hundreds of strains of meningococcus B, the most common cause of bacterial meningitis.
Certain Painkillers May Raise Odds of Stroke, Heart Attack: Study
July 14, 2011
Heart disease patients with high blood pressure who take a class of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) are at greater risk for heart attack, stroke or even death, new research shows.
Delving Into the Mystery of Placebos
July 13, 2011
A new study finds that the power of the placebo effect left asthma patients thinking that real and fake drugs were doing the same level of good, even though the real medication actually had a much greater physical effect on their lungs.
For Some Prostate Cancer Patients, Combo Treatment Improves Survival
July 13, 2011
For men who have prostate cancer that's considered "intermediate risk," radiation plus four months of hormone therapy appears to improve survival, a new study finds.
Drugs May Prevent HIV Spread Among Heterosexuals
July 13, 2011
Giving antiretroviral drugs to heterosexuals at high risk of HIV infection can significantly reduce the chance they will develop the AIDS-causing virus, two new studies suggest.
Parkinson's Patients Still Prescribed Antipsychotics Despite Warning
July 11, 2011
Antipsychotic drugs are still prescribed to more than half of American patients with Parkinson's disease and psychosis even though a warning that these drugs can worsen Parkinson's symptoms was issued six years ago, a new study reveals.
Gonorrhea's Growing Resistance to Antibiotics Concerns CDC
July 7, 2011
Gonorrhea appears to be growing increasingly resistant to drugs called cephalosporins, the only remaining class of antibiotics available to treat the sexually transmitted disease, according to a new report.
FDA MedWatch Alerts
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