You received this email because you are subscribed to updates from Drugs.com. Change your notification settings or unsubscribe here.

Drugs.com Logo
Newsletter
Vol 90 - February 2012
Featured News
Monthly Roundup - February 2012
February 2012
Inlyta Approved For Advanced Renal Cell Carcinoma Inlyta (axitinib) is an oral kinase inhibitor approved for the treatment of advanced renal cell carcinoma (kidney cancer) in adults after failure of one prior therapy. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: February 17, 2012
Treatment for: Cushing's Syndrome
Korlym Drug Information | Press Release
Date of Approval: February 14, 2012
Treatment for: Hypogonadism -- Male
Bio-T-Gel Drug Information | Press Release
Date of Approval: February 10, 2012
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension
Zioptan Drug Information | Press Release
Date of Approval: February 7, 2012
Treatment for: Lice
Sklice Drug Information | Press Release
Date of Approval: February 7, 2012
Treatment for: Glaucoma Surgery
Mitosol Drug Information | Press Release
Date of Approval: January 30, 2012
Treatment for: Diabetes Mellitus Type II
Jentadueto 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: February 2, 2012
Now Approved: Janumet XR
Janumet Drug Information | Press Release
New Formulation Approved: February 29, 2012
Now Approved: Lower Dose Formulation
Angeliq Drug Information | Press Release
New Indication Approved: January 31, 2012
Now Approved for: Maintenance Treatment of ADHD in Adults
Vyvanse 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.
Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution

Approved: January 25, 2012 - Novel Laboratories, Inc.
Generic for: Moviprep For Oral Solution
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
Autoinjector Version of MS Drug Approved
February 28, 2012
A pen-delivery version of the multiple sclerosis drug Avonex has been approved by the United States Food and Drug Administration, drug manufacturer Biogen Idec said Tuesday.
Many Vegetarians Unaware of Animal-Derived Gels in Pills
February 28, 2012
Vegetarians and others who avoid eating meat for religious or cultural reasons may unknowingly be consuming gelatin derived from animal products when they take prescription medications, a new study found.
Sleeping Pills Linked to Raised Risk of Death, Cancer: Study
February 27, 2012
Prescription sleeping pills may help you get some much needed rest at night, but using them routinely might also make it more likely that you will die or develop certain types of cancer, research suggests.
Certain Antipsychotics Up Risk of Death for Patients With Dementia: Study
February 23, 2012
Compared to other antipsychotic drugs, haloperidol (Haldol) raises the risk of death in elderly patients with dementia, a new study finds.
Contraceptives Work Well in Obese Women, But Hormone Levels Lower
February 23, 2012
Hormonal contraceptives appear to thwart pregnancy just as well in overweight and obese women as those of normal weight despite markedly lower pregnancy-prevention hormone levels among heavier females, a group of reproductive experts said.
All U.S. Adults Should Get Whooping Cough Shot: Panel
February 22, 2012
U.S. health experts recommended Wednesday that all adults get vaccinated against whooping cough, an infectious bacterial disease that triggers uncontrollable coughing and is especially dangerous to infants.
FDA Moves to Head Off Shortages of 2 Cancer Drugs
February 21, 2012
The U.S. Food and Drug Administration announced Tuesday what it called a series of steps to ensure the continued availability of vital cancer drugs that have been in dangerously short supply.
Implanted Microchip Might Be Future of Drug Delivery
February 16, 2012
Remote controls may not be for just appliances anymore.
Treatment Advances Improve the Odds for Heart Failure Patients
February 16, 2012
Although a growing number of Americans now struggle with heart failure, experts say new treatments have dramatically improved both quality of life and life expectancy for these patients.
New Blood Thinner May Prevent Blood Clots During Cancer Treatment
February 15, 2012
A new blood-thinning medication called semuloparin reduces the risk of blood clots in people undergoing certain cancer treatments, new research shows.
Stop-Smoking Drug May Also Curb Problem Drinking
February 15, 2012
The quit-smoking drug Chantix may also help problem drinkers cut their alcohol consumption, a small new study suggests.
Illicit Drugs Bought Off Internet May Be Poisons, Experts Warn
February 9, 2012
A case study of two men who were poisoned and turned blue after ingesting what they thought was a recreational drug that they had bought on the Internet highlights the dangers of such purchases, a new report claims.
More People Need Training in Lifesaving Epinephrine Use, Advocates Say
February 9, 2012
When Jane Able's 4-year-old daughter, Ellie, was diagnosed with a severe peanut allergy, the New Albany, Ohio, mother got trained in using an epinephrine pen and never leaves home without it.
Generic Drugs Easing Out-of-Pocket Medical Costs in U.S.
February 8, 2012
More Americans are buying the generic forms of medications, and this practice has made their prescriptions more affordable, according to a new report.
Breast Cancer Drug May Weaken Bones, Study Finds
February 7, 2012
A drug used to prevent breast cancer in women at high risk for the disease appears to cause bone loss in some postmenopausal women, a new study finds.
Metformin Preferred Drug for Type 2 Diabetes, Experts Say
February 6, 2012
When it comes to the treatment of type 2 diabetes, the first line of defense is lifestyle changes such as losing weight and exercising more often.
FDA MedWatch Alerts
Tools & Helpful Links
Community Discussion Forums
We welcome you to share your experiences.
Medical Encyclopedia
Use this feature to find information on diseases, symptoms, injuries, medical tests and surgical procedures.
Browse by Medical Condition
Use this feature to find drugs or medication related to a condition or therapeutic group.
Pill Identifier
The Pill Identifier enables a search for unidentified pills by imprint code or shape/color.
Drug Interactions Checker
Increasingly popular as more healthcare professionals and consumers make the effort to seek detailed information on drug-drug and drug-food interactions.
New Drugs
All the latest information on FDA Approvals and recent additions to the database.
News & Articles
Roundup of recent drug-related news and press releases. also latest news from FDA Medwatch service including timely publication of recalls, withdrawals, warnings, and label/packaging changes.
Drugs.com Daily 300x250
powered byad choices
About This Newsletter
Drugs.com is not affiliated with any pharmaceutical company. We are dedicated to providing consumers and health professionals with objective information about prescription-medication discoveries and side effects.
This information is not intended to be medical advice. You should contact your physician before making any changes to your health care. Drugs.com is not responsible for content provided by third-party web sites.
About Your Subscription
You received this email because you are subscribed to updates from Drugs.com. Change your notification settings or unsubscribe here.
Your Feedback
We always appreciate feedback so if you wish to give us your comments/ praise/ rebuke please Contact Us.
Thanks so much for your continued support!
The Editorial Team
Drugs.com
Your Privacy - Any personal information you provide to us will only be used to notify you of offers, information and activities.
We'll hold the information about you securely and will not disclose it except for this purpose, or when required by law.
Copyright © 2012 Drugs.com. All Rights Reserved.

You received this email because you are subscribed to updates from Drugs.com. Change your notification settings or unsubscribe here.