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Newsletter
Vol 89 - January 2012
Featured News
Monthly Roundup - January 2012
January 2012
Bydureon Approved: First Once-A-Week Treatment for Type 2 Diabetes Amylin Pharmaceuticals received FDA-approval of Bydureon (exenatide extended-release for injectable suspension), a once-a-week, 2 mg injection used in conjunction with diet and exercise to improve glycemic control in type 2 diabetics. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: January 31, 2012
Treatment for: Cystic Fibrosis
Kalydeco Drug Information | Press Release
Date of Approval: January 30, 2012
Treatment for: Basal Cell Carcinoma
Erivedge Drug Information | Press Release
Date of Approval: January 27, 2012
Treatment for: Diabetes Mellitus Type II
Bydureon Drug Information | Press Release
Date of Approval: January 27, 2012
Treatment for: Renal Cell Carcinoma
Inlyta Drug Information | Press Release
Date of Approval: January 23, 2012
Treatment for: Actinic Keratosis
Picato Drug Information | Press Release
Date of Approval: January 20, 2012
Treatment for: Allergic Rhinitis
Zetonna Drug Information | Press Release
Date of Approval: January 17, 2012
Treatment for: Toxic Methotrexate Levels
Voraxaze Drug Information | Press Release
Date of Approval: January 4, 2012
Treatment for: Pain
Subsys 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 Regimen: January 23, 2012
Now Approved: Subcutaneous Administration
Velcade Drug Information | Press Release
Patient Population Altered: December 30, 2011
Now Approved for: People Aged 50 and Older
Prevnar 13 Drug Information | Press Release
Patient Population Altered: January 19, 2012
Now Approved for: Children Aged 2-12 Years with HIV
Viread 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.
Methylphenidate Hydrochloride Extended-Release Capsules (LA)
20 mg, 30 mg and 40 mg
Approved: December 1, 2011 - Actavis South Atlantic LLC
Generic for: Ritalin LA Capsules
Felbamate Oral Suspension
600 mg/5 mL
Approved: December 16, 2011 - Amneal Pharmaceuticals
Generic for: Felbatol Oral Suspension
Fenofibrate Tablets
48 mg and 145 mg
Approved: December 23, 2011 - Lupin Limited
Generic for: Tricor Tablets
Tramadol Hydrochloride Extended-Release Tablets
100 mg, 200 mg and 300 mg (Once Daily)
Approved: December 30, 2011 - Sun Pharma Global FZE
Generic for: Ryzolt Tablets
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for December 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
Multaq
(dronedarone hydrochloride) tablets
x x - - - - - -
Dilantin-125
(phenytoin) Oral Suspension
- x - x x - - -
Norvir
(ritonavir) Soft Gel capsules, tablets, and oral solution
- x x x x x - -
Relenza
(zanamivir) inhalation powder
- x - - - x - -
Tyzeka
(telbivudine) tablets and oral solution
- x x x - - - -
Capoten
(captopril) Tablets 
- - x x - - - -
Danocrine brand of Danazol capsules
- - x x x - - -
Desferal
(deferoxamine mesylate) for injection
- - x x - - - -
Edarbi
(azilsartan medoxomil) Tablets 
- - x x - x - -
Eloxatin
(oxaliplatin)  for intravenous use
- - x x - - - -
Heparin Sodium Injection
- - x x - - - -
Isentress
(raltegravir) scored, chewable tablets, film coated tablets
- - x x x - - -
Keppra
(levetiracetam) Tablets and oral solution
- - x x - - - -
Keppra
(levetiracetam) Tablets and oral solution
- - x x - - - -
Onglyza
(saxagliptin) tablets
- - x x x - - -
Ovide
(malathion) 0.5% lotion
- - x - x - - -
PegIntron
(Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use
- - x x - - - -
Plavix
(clopidogrel bisulfate) tablets
- - x x - - - -
Remeron
(mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating tablets
- - x - - - - -
Zegerid
(omeprazole/sodium bicarbonate) powder for oral suspension and capsules
- - x x - - - -
Avapro
(irbesartan) Tablets
- - - x x - - -
Diovan HCT
(valsartan/hydrochloriothiazide) Tablets
- - - x - x - -
Exforge HCT
(amlodipine, valsartan, hydrochlorothiazide) tablets
- - - x - - - -
Isoptin SR
(verapamil hydrochloride) tablets
- - - x - - - -
Nexterone
(Amiodarone Hydrochloride) Premixed Injection for Intravenous Use
- - - x - - - -
Solaraze
(diclofenac sodium) gel 3%
- - - x - - - -
Sustiva
(efavirenz) capsules and tablets
- - - x - - - -
suspension)
(albumin-bound), 100 milligram vial
- - - - x - - -
Avastin
(bevacizumab) Solution for intravenous infusion
- - - - x - - -
Cleviprex
(clevidipine) 0.5 mg/mL injectable emulsion
- - - - x - - -
Elestat
(epinastine hydrochloride ophthalmic solution) 0.05%
- - - - x - - -
Femara
(letrozole) tablets
- - - - x - - -
Prezista
(darunavir) suspension and tablets
- - - - x - - -
Proleukin
(aldesleukin)
- - - - x - - -
Protonix
(pantoprazole sodium) for injection
- - - - x - - -
Singulair
(montelukast sodium) Tablets, Chewable Tablets, and Oral Granules
- - - - x x - -
Toviaz
(fesoterodine fumarate) extended release tablets
- - - - x - - -
Vancocin 
(vancomycin hydrochloride) Capsules
- - - - x - - -
Bystolic
(nebivolol) Tablets
- - - - - - - -
Diovan
(valsartan) Tablets
- - - - - x - -
Vytorin
(ezetimibe/simvastatin) Tablets
- - - - - 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
Researchers Spot Potential Bile Duct Cancer Drug Targets
January 26, 2012
Researchers who identified a new genetic signature associated with bile duct cancer say their discovery could lead to targeted treatment for the deadly cancer.
Study Finds No Link Between HPV Vaccine and Autoimmune Disorders
January 26, 2012
The human papillomavirus (HPV) vaccine Gardasil does not trigger autoimmune disorders such as rheumatoid arthritis, lupus, type 1 diabetes or multiple sclerosis, according to a two-year study that included nearly 190,000 girls and women.
Women Can Take Steps to Prevent Cervical Cancer
January 25, 2012
Women need to get recommended Pap tests, while girls and young women should be vaccinated against human papillomavirus (HPV) to protect them from cervical cancer, the American College of Obstetricians and Gynecologists advises during Cervical Health Awareness Month.
Drug May Slow Early Prostate Cancer: Study
January 24, 2012
New research suggests that Avodart, a drug used to treat an enlarged prostate gland, may help slow the progression of early stage prostate cancer, reducing the need for aggressive treatment in some men.
Melanoma Drug's Link to Other Skin Cancers Identified
January 18, 2012
The recently approved drug vemurafenib (Zelboraf) has been hailed as a breakthrough in the treatment of melanoma, the deadliest form of skin cancer.
New Drug Combo for Hepatitis C Shows Promise
January 18, 2012
A new cocktail of two investigational drugs appears to have successfully cleared the hepatitis C virus in people who don't respond to standard treatment.
Drug Duo May Help Fight Aggressive Form of Breast Cancer
January 17, 2012
Combining two drugs that target an aggressive type of breast cancer known as HER2-positive appears to work better than using either drug alone, researchers report.
'Bath-Salts' Injection Leads to Flesh-Eating Disease
January 16, 2012
The use of street drugs known as "bath salts" can lead to flesh-eating disease, a new study warns.
Herbal Medicines for Arthritis Not Backed by Evidence
January 11, 2012
There is little evidence to support the widespread use of herbal medicines to relieve the symptoms of osteoarthritis, according to a review of these products.
Study Challenges Potassium Guidelines for Heart Attack Patients
January 10, 2012
Heart attack patients whose blood potassium levels are within a certain range are less likely to die than those with levels of the mineral below or above that range, says a new study that challenges current recommendations for potassium levels in heart attack patients.
Too Much Vitamin D Could Be Harmful to Heart
January 10, 2012
Studies have shown that vitamin D is critical for bone health and could have a protective benefit for the heart, but new research suggests that too much of it could actually be harmful.
New Blood Thinner Linked To Higher Heart Attack Risk
January 9, 2012
The anticoagulant Pradaxa (dabigatran) is associated with a small increase in the risk of heart attack, a new review finds.
Low-Dose Aspirin to Prevent First Heart Attack or Stroke? Not So Fast
January 9, 2012
For years, people have been told that low-dose aspirin can help reduce their risk of dying from a heart attack, stroke or cancer even if they are healthy.
FDA MedWatch Alerts
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