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Newsletter
Vol 76 - December 2010
Featured News
Drug Abuse Treatment Rates on the Rise: U.S. Report
December 2010
Admissions for alcohol abuse treatment have remained the same in parts of the Midwest and South while dropping elsewhere in the United States, while treatment rates for illegal drugs are increasing across the country, especially for marijuana abuse, according to a new report. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
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: December 13, 2010
Now Approved: Prezista/ritonavir Once-Daily Dosing
Prezista 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.
Gemcitabine Hydrochloride Injection
2 g base/vial
Approved: November 15, 2010 - Hospira Inc.
Generic for: Gemzar
Zafirlukast Tablets
10 mg and 20 mg
Approved: November 18, 2010 - Dr Reddys Laboratories Ltd.
Generic for: Accolate
Levocetirizine Dihydrochloride Tablets
5 mg
Approved: November 26, 2010 - Synthon Pharmaceuticals, Inc.
Generic for: Xyzal
Topotecan Hydrochloride Injection
4 mg base/vial
Approved: November 29, 2010 - APP Pharmaceuticals, LLC; Fresenius Kabi
Generic for: Hycamtin
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for November 2010. 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
Rifadin
(rifampin capsules USP), and Rifadin (rifampin for injection USP) IV
- x - x x - - -
Rifater
(rifampin, isoniazid and pyrazinamide) Tablets
- x - x x - - -
Feraheme
(ferumoxytol) Injection
- - x x - - - -
Rapamune
(sirolimus) Oral Solution and Tablets
- - x x x - - -
Reglan
(metoclopramide) Tablets, ODT, and Injection
- - x - - - - -
Revatio
(sildenafil) Tablets and Injection
- - x x x - - -
Zemuron
(rocuronium bromide) Injection
- - x x - - - -
Adderall XR
(dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules
- - - x - - - -
Cardizem CD
(diltiazem hydrochloride) Capsules and Tablets Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets
- - - x x - - -
Metopirone
(metyrapone USP) 250 mg, Capsules
- - - x x - - -
Rozerem
(ramelteon) Tablets
- - - x - - - -
Tiazac
(diltiazem hydrochloride) Extended Release Capsules
- - - x x - - -
Trandate
(labetalol hydrochloride) Tablets and Injection
- - - x - - - -
Vfend
(voriconazole) Tablets, Injection, and Oral Suspension
- - - x - - - -
Vyvanse
(lisdexamfetamine dimesylate) Capsules
- - - x x - - -
Byetta
(exenatide) Injection
- - - - x - - -
Crestor
(rosuvastatin calcium) Tablets
- - - - x - - -
Eraxis
(anidulafungin) for Injection
- - - - x - - -
Glucovance
(glyburide and metformin HCl) Tablets
- - - - x - - -
MoviPrep
(PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride,Sodium Ascorbate, and Ascorbic Acid for Oral Solution)
- - - - x - - -
Nucynta
(tapentadol) Immediate-release Oral Tablets
- - - - x - - -
Olux-E
(clobetasol propionate) Foam, 0.05 %
- - - - x - - -
OxyContin
(Oxycodone Hydrochloride Controlled-Release) Tablets
- - - - x - - -
Paraplatin
(carboplatin) for Injection
- - - - x - - -
Tamiflu
(oseltamivir phosphate) Capsules and Oral Suspension
- - - - x - - -
Sustiva
(efavirenz) Tablets and Capsules
- - - - x - - -
Zocor
(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
For Cholesterol Control, Experts Urge More Than Meds
December 28, 2010
Advances in medical science have made it easier than ever to lower dangerous cholesterol levels.
Roundup: 2010 Advances in Heart Disease and Stroke Care
December 28, 2010
2010 was a year that enjoyed continued advances in the treatment of heart disease and stroke, according to the American Heart Association/American Stroke Association.
Type of Formula May Influence Infant Weight Gain
December 27, 2010
The kind of formula babies drink has a major impact on weight gain and could affect their future risk of developing obesity, diabetes and other diseases, new research suggests.
Lupus Treatment May Soon Take Leap Forward
December 24, 2010
For years now, doctors have made slow, incremental progress in the treatment of lupus, a chronic autoimmune condition that can wrack the body and seriously affect a person's health.
Placebos Work -- Even if Patients Are in on the Secret
December 22, 2010
Confronting the "ethically questionable" practice of prescribing placebos to patients who are unaware they are taking dummy pills, researchers found that a group that was told their medication was fake still reported significant symptom relief.
Does 'Club Drug' Ecstasy Have Therapeutic Value?
December 21, 2010
The recreational drug known as ecstasy may have a medicinal role to play in helping people who have trouble connecting to others socially, new research suggests.
Echinacea No Cure for the Common Cold, Study Finds
December 20, 2010
The herbal remedy echinacea, believed by many to cure colds, is no better than a placebo in relieving the symptoms or shortening the duration of illness, a new study finds.
Heartburn Drugs May Raise Pneumonia Risk
December 20, 2010
Popular heartburn drugs, including proton pump inhibitors and histamine-2 receptor antagonists, may raise the risk of pneumonia, new research finds.
Keeping Holiday Drinking in Check May Counter Cancer
December 19, 2010
Though holiday partying often includes alcohol consumption, cancer experts are urging partiers to partake moderately.
Hectic Holiday Pace Can Upset Medication Schedule
December 18, 2010
The hectic pace of the holiday season can make it difficult for people with chronic pain or other persistent health conditions to maintain normal routines and medication schedules.
FDA Advises Against Avastin as Treatment for Breast Cancer
December 16, 2010
Federal health officials on Thursday recommended revoking approval of the drug Avastin to fight breast cancer, citing the medication's poor performance in follow-up studies and its potential for serious side effects.
Inhalers Linked to Higher Odds of Diabetes in Asthma, COPD Patients
December 16, 2010
Asthma and chronic obstructive pulmonary disease (COPD) patients who are treated with inhaled corticosteroids may face a significantly higher relative risk for both the development and progression of diabetes, new Canadian research suggests.
U.S. Spending Millions to See if Herbs Truly Work
December 16, 2010
People have been using herbal supplements for centuries to cure all manner of ills and improve their health.
Certain Drug Combinations May Beat Back Aggressive Breast Cancer
December 10, 2010
Combinations of targeted therapies for an especially aggressive type of breast cancer could potentially usher the majority of affected patients into remission, researchers at a major breast cancer meeting said Friday.
Bone Drug Zometa Flops Overall as Breast Cancer Treatment
December 9, 2010
The bone drug zoledronic acid (Zometa), considered a potentially promising weapon against breast cancer recurrence, has flopped in a new study involving more than 3,360 patients.
40 Million in U.S. Driving Drunk or Drugged
December 9, 2010
Despite massive efforts to curb drunk driving, some 30 million Americans are driving drunk and another 10 million are driving drugged each year, federal officials report.
Daily Aspirin Linked to Steep Drop in Cancer Risk
December 6, 2010
Long-term use of a daily low-dose aspirin dramatically cuts the risk of dying from a wide array of cancers, a new investigation reveals.
Daily Sunscreen Use Does Protect from Melanoma, Study Finds
December 6, 2010
Applying sunscreen every day to the head, neck, arms and hands reduced the chances of getting melanoma by half, a new study has found.
FDA MedWatch Alerts
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