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Newsletter
Vol 82 - June 2011
Featured News
Monthly Roundup - June 2011
June 2011
Abuse-resistant Pain Drug Oxecta™ Approved With New AVERSION® Technology Oxycodone pain drug Oxecta™ approved with added benefit to help combat opioid abuse Read more... Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: June 21, 2011
Treatment for: Anal Fissure and Fistula
Rectiv Drug Information | Press Release
Date of Approval: June 17, 2011
Treatment for: Pain
Oxecta Drug Information | Press Release
Date of Approval: June 15, 2011
Treatment for: Organ Transplant -- Rejection Prophylaxis
Nulojix Drug Information | Press Release
Date of Approval: June 10, 2011
Treatment for: Seizures
Potiga Drug Information | Press Release
Date of Approval: June 8, 2011
Treatment for: Cough and Nasal Congestion
Zutripro Drug Information | Press Release
Date of Approval: June 8, 2011
Treatment for: Cough and Nasal Congestion
Rezira 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 Dosage Form Approved: June 10, 2011
Now Approved: Infant-Specific Dosage Strength
Creon Drug Information | Press Release
New Dosage Regimen: June 17, 2011
Now Approved: Six-Month Formulation
Lupron Depot Drug Information | Press Release
New Indication Approved: June 16, 2011
Now Approved for: Peripheral T-Cell Lymphoma
Istodax 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.
Fluticasone Propionate Topical Lotion
0.05%
Approved: May 2, 2011 - Glenmark Generics Inc.
Generic for: Cutivate Lotion
Methylergonovine Maleate Tablets
0.2 mg
Approved: May 2, 2011 - Novel Laboratories, Inc.
Generic for: Methergine Tablets
Bromfenac Sodium Ophthalmic Solution/Drops
0.09%
Approved: May 11, 2011 - Coastal Pharmaceuticals
Generic for: Xibrom
Nitrofurantoin Oral Suspension
25 mg/5 mL
Approved: May 11, 2011 - Amneal Pharmaceuticals
Generic for: Furadantin Suspension
Budesonide Capsules
3 mg
Approved: May 16, 2011 - Mylan Pharmaceuticals Inc.
Generic for: Entocort EC
Lamivudine and Zidovudine Tablets
150 mg/300 mg
Approved: May 25, 2011 - Teva Pharmaceuticals USA Inc.
Generic for: Combivir
Ethinyl Estradiol/Levonorgestrel and Ethinyl Estradiol Tablets
0.03 mg/0.15 mg and 0.01 mg
Approved: May 31, 2011 - Watson Laboratories, Inc.
Generic for: Seasonique
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
FDA Panel Rejects Avastin for Breast Cancer
June 29, 2011
The blockbuster cancer drug Avastin got soundly rejected late Wednesday as a treatment for metastatic breast cancer by a United States health advisory panel that found the medication was not effective and causes dangerous side effects.
Addiction Starts Early in American Society, Report Finds
June 29, 2011
A new study reveals that 90 percent of Americans who are addicted to tobacco, alcohol or other substances started smoking, drinking or using drugs before they were 18 years old.
Flu Shots for Pregnant Women Also Protect Newborns, Study Finds
June 29, 2011
Giving flu shots to pregnant women also protects their newborns, researchers say.
Class of Drugs Linked to Higher Heart Risk in Older Diabetics
June 25, 2011
New research shows that older people with type 2 diabetes who take drugs known as sulfonylureas to lower their blood sugar levels may face a higher risk for heart problems than their counterparts who take metformin.
Surge in Number of Americans Treated for Prescription Painkiller Abuse
June 23, 2011
Rehab admissions related to alcohol, opiates (including prescription painkillers) and marijuana increased in the United States between 1999 and 2009, according to a new national report.
New Drug Effectively Treats Hepatitis C
June 22, 2011
The recently approved drug Incivek, combined with two standard drugs, is highly effective at treating hepatitis C, a notoriously difficult-to-manage liver disease, two new studies show.
Some Drugs for Rheumatoid Arthritis, Psoriasis May Cut Diabetes Risk
June 21, 2011
Some medications commonly used to treat rheumatoid arthritis and psoriasis may help patients with these autoimmune disorders lower their risk of developing diabetes, researchers say.
Millions Don't Get Meds for Serious Artery Disease: Study
June 20, 2011
Millions of Americans suffer from a condition known as peripheral artery disease but aren't receiving medical treatment, putting them at risk of potentially fatal heart problems, a new study finds.
Study Finds Botox Alternative Better at Smoothing 'Crow's Feet'
June 20, 2011
A more recently approved version of botulinum toxin type A beat the anti-wrinkle medication Botox in a trial that compared the respective powers of each in erasing those unwanted lines of aging around the eyes known as "crow's feet".
Rise in Drug-Related Suicide Attempts by Young Men Alarms Experts
June 17, 2011
U.S. emergency department visits for drug-related suicide attempts by young adult males rose 55 percent between 2005 and 2009, a government report says.
Proper Bowel Prep Key to Effective Colon Cancer Screening: Study
June 15, 2011
Inadequate bowel-cleansing before a colonoscopy can result in high miss rates for precancerous polyps (adenomas) and a need for earlier repeat tests, a new study finds.
Study Finds Equal Number of Errors in Hospitals, Doctors' Offices
June 14, 2011
Your chances of suffering harm because of a medical error are about the same in a doctor's office as in a hospital, according to a new study.
New Test Helps Evaluate Breast Cancer Patients for Herceptin Use
June 14, 2011
A genetic test to help doctors evaluate whether women with breast cancer are candidates for treatment with the drug Herceptin (trastuzumab) has been approved by the United States Food and Drug Administration.
Most U.S. Kids Get Recommended Vaccines: CDC
June 9, 2011
Although nearly all American children get the recommended vaccinations to prevent serious diseases, many parents express concerns about the shots, and a small number refuse to have their kids inoculated, according to the Centers for Disease Control and Prevention.
New Guidelines Put Focus on Vitamin D Deficiency
June 8, 2011
It has long been known that getting enough vitamin D is key to bone health, yet vitamin D deficiency remains a common health issue, experts say.
Melanoma Vaccine Shows Promise in Trial
June 1, 2011
For patients with advanced melanoma, the most dangerous type of skin cancer, a vaccine combined with an immune-boosting drug is showing promise in a large clinical trial.
FDA MedWatch Alerts
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