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Newsletter
Vol 77 - January 2011
Featured News
New Oral Drugs Hailed for Treating Multiple Sclerosis
January 2011
For decades, research into treatments for multiple sclerosis has plodded forward, making slow but significant gains in improving the lives of people with the degenerative nerve disorder. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: January 21, 2011
Treatment for: Depression
Viibryd Drug Information | Press Release
Date of Approval: January 18, 2011
Treatment for: Lice
Natroba Drug Information | Press Release
Date of Approval: January 14, 2011
Treatment for: Diagnostic
DaTscan Drug Information | Press Release
Date of Approval: January 7, 2011
Treatment for: Pain
Abstral 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.
Zolpidem Tartrate Extended-Release Tablets
12.5 mg
Approved: December 3, 2010 - Anchen Pharmaceuticals, Inc.
Generic for: Ambien CR Tablets, 12.5 mg
Levofloxacin Ophthalmic Solution
0.5%
Approved: December 20, 2010 - Apotex Inc.; Nexus Pharmaceuticals, Inc.; Akorn Inc.
Generic for: Quixin Ophthalmic Solution
Dutasteride Capsules
0.5 mg
Approved: December 21, 2010 - Barr Laboratories, Inc.
Generic for: Avodart Capsules
Doxycycline Hyclate Delayed-Release Tablets
USP, 75 mg (base) and 100 mg (base)
Approved: December 28, 2010 - Impax Laboratories, Inc.; Mylan Pharmaceuticals, Inc.
Generic for: Doryx Tablets
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for December 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
Ablavar
(gadofosveset trisodium) injection
x - x x - - - -
Aceon
(perindopril erbumine) tablets
x x - - x - - -
Eovist
(Gadoxetate disodium) injection
x - x x - - - -
Magnevist
(gadopentetate dimeglumine) injection and pharmacy bulk package injection
x x x x - - - -
MultiHance
(gadobenate dimeglumine) injection
x - x x - - - -
Omniscan
(gadodiamide) injection and pharmacy bulk package injection
x x x x - - - -
Optimark
(gadoversetamide) injection and pharmacy bulk package injection
x x x - - - - -
Prohance
(gadoteridol) injection and multipack injection
x - x x - - - -
Copegus
(ribavirin) tablets
- x x x - - - -
Terconazole Vaginal Cream
- x - - x - - -
Baraclude
(entecavir) tablets and oral solution
- - x x x - - -
Innopran XL
(propranolol hydrochloride) capsules
- - x x x - - -
Pristiq
(desvenlafaxine) extended-release tablets
- - x x - - - -
Relenza
(zanamivir) inhalation powder
- - x x x - - -
Remicade
(inflximab ) for Intravenous (IV) injection
- - x - x - - -
Zegerid OTC capsules
- - x - - - - -
Zerit
(stavudine) capsules and oral solution
- - x x x - - -
Arthrotec
(diclofenac sodium/misoprostol) oral tablets
- - - x - - - -
Campral
(acamprosate calcium) delayed-release tablets
- - - x - - - -
Carafate
(sucralfate) suspension
- - - x x - - -
Clinoril
(sulindac) tablets
- - - x - - - -
Dermatop
(prednicarbate cream) Cream and Dermatop (prednicarbate ointment) ointment
- - - x - - - -
Inomax
(nitric oxide) inhalation
- - - x - - - -
Ketek
(telithromycin) tablets
- - - x - - - -
Riomet
(metformin HCl) oral solution
- - - x - - - -
Serevent Diskus
(salmeterol xinafoate) inhalation powder
- - - x - - - -
Tamiflu
(oseltamivir phosphate) capsules and oral suspension
- - - x - - - -
Uroxatral
(alfuzosin HCL) extended-release tablets
- - - x - - - -
Zyprexa Relprevv
(olanzapine) for extended release injectable suspension
- - - x - - - -
Chantix
(varenicline) tablets
- - - - x - - -
Cordarone
(amiodarone HCl) tablets
- - - - x - - -
Cubicin
(daptomycin) for injection
- - - - x - - -
Intelence
(etravirine) tablet
- - - - x - - -
Timentin
(sterile ticarcillin disodium and clavulanate potassium) for intravenous administration
- - - - x - - -
Treanda
(bendamustine hydrochloride) lyophilized solid for injection
- - - - x - - -
Velcade
(bortezomib) for injection
- - - - x - - -
Victoza
(liraglutide [rDNA origin]) injection
- - - - x - - -
Vytorin
(ezetimibe/simvastatin) tablets
- - - - x x - -
Xolegel
(ketoconazole) topical gel
- - - - x - - -
Prezista
(darunavir) tablets
- - - - - - - -
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
New U.S. Dietary Guidelines Focus on Salt Reduction
January 31, 2011
Long-awaited United States dietary guidelines released Monday - the first since 2005 - focus on getting Americans to slash their salt intake.
Will Loss of Lethal Injection Drug Harm Surgical Patients?
January 28, 2011
Anesthesiologists say they have grave concerns over a decision by a drug manufacturer to halt production of a long-used and powerful anesthetic because of the medication's use in lethal injections in prison executions.
Fear of Vaccines Has a Long, Persistent History
January 26, 2011
As long as vaccinations against disease have been around, there have been die-hard opponents convinced that these shots do more harm than good.
Smoking, Obesity Slowing U.S. Life Expectancy, Report Finds
January 25, 2011
Longevity isn't increasing as fast in the United States as it is in other developed countries, says a new report that points a finger at high rates of smoking and obesity.
Preparing Small Doses of Medication From Syringes Called Risky
January 24, 2011
Preparing small doses of medications from syringes can be inaccurate and lead to dangerous dosing errors for infants and small children, warns a new study.
Severe Mental Health Disorders Untreated in Many U.S. Teens
January 21, 2011
Among American teens, many with severe mental disorders never receive treatment, the results of a new study suggest.
Pain Patches Making Gains in U.S.
January 21, 2011
Americans suffering from muscle pain are used to taking a pill or rubbing in a cream to help soothe their aches.
Slightly More Than Half of Americans Say Vaccines Don't Cause Autism: Poll
January 20, 2011
Just a slim majority of Americans - 52 percent - think vaccines don't cause autism, a new Harris Interactive/HealthDay poll found.
Study Questions Safety of Pneumonia Treatment Guidelines
January 19, 2011
Intensive care patients who may be infected with strains of pneumonia that are resistant to many drugs may be more likely to die if current treatment guidelines are followed, a new study suggests.
Warfarin Use May Raise Risk of Death From Traumatic Injuries
January 17, 2011
New research shows that the risk of dying after suffering a traumatic injury is much higher for people taking warfarin, the most commonly used blood thinner in America.
Some Antibiotics, Blood Pressure Meds a Bad Mix: Study
January 17, 2011
Older people who are taking common blood pressure medications called calcium channel blockers face an increased risk of developing dangerously low blood pressure and possibly going into shock if they take certain antibiotics, Canadian researchers warn.
New Guidelines Released for Stroke Care
January 14, 2011
Improving how quickly stroke patients are diagnosed and treated is the cornerstone of a new set of recommendations from the American Heart Association/American Stroke Association.
Pill-Splitting Potentially Perilous, Study Suggests
January 13, 2011
The common practice of pill-splitting - done by patients and health professionals alike to save money or make medications easier to swallow - is inaccurate and potentially dangerous, a new study suggests.
Antibiotics Can Ease Kids' Ear Infections, Studies Show
January 12, 2011
Amid the ongoing controversy over routine antibiotic use for children with acute ear infections, two new studies support the practice when stringent diagnostic criteria are met.
U.S. Officials Recommend Reduced Fluoride Levels in Water
January 7, 2011
U.S. government officials said Friday that the amount of fluoride in the nation's drinking water should now be set at the lowest recommended level.
No Surgery for Moderate Tonsillitis, New Guidelines Say
January 6, 2011
Doctors should use antibiotics and a wait-and-see approach when treating repeated throat infections in children and resort to a tonsillectomy only in the most severe cases, new medical guidelines suggest.
Guidelines Issued for Drug-Resistant Staph Infections
January 6, 2011
An infectious disease association has released the first national guidelines for the treatment of potentially deadly methicillin-resistant Staphylococcus aureus (MRSA) infections.
Fish Oil May Help Some Heart Failure Patients
January 5, 2011
For heart failure patients whose condition is controlled with standard care, omega-3 fatty acid supplements appear to improve their condition even more, a small study suggests.
FDA Launches Review of Tobacco Products
January 5, 2011
Tobacco products introduced or altered since February 2007 must be reviewed by the United States Food and Drug Administration if they are to remain on the market, the agency announced Wednesday.
More Evidence Links Avastin to Heart Failure in Breast Cancer Patients
January 4, 2011
Just weeks after United States health officials moved to rescind approval of the drug Avastin to treat breast cancer, a new study provides more evidence that the anti-cancer medication ups the odds of congestive heart failure in these patients.
Pop Star's Use of Salvia Puts Hallucinogen in the Spotlight
January 4, 2011
After a video surfaced on the Internet last month of pop star Miley Cyrus - giggling and semi-coherent, holding a bong - many wondered what the 18-year-old singer had inhaled.
Estrogen May Play Role in Rising Rates of Head, Neck Cancer
January 4, 2011
Rates of head and neck cancer are rising among some groups of people, including young women without any known risk factors.
Studies Decipher How Anti-Smoking Drugs Work
January 3, 2011
Two drugs that help people stop smoking - bupropion and varenicline - may change the way the brain reacts to seeing someone else smoke, new studies report.
FDA MedWatch Alerts
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