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Newsletter
Vol 74 - October 2010
Featured News
Teens, Parents Often Lie About Illicit Drug Use
October 2010
Don't expect teens - or their parents - to be honest about their drug use, a new study shows. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: October 28, 2010
Treatment for: Schizophrenia
Latuda Drug Information | Press Release
Date of Approval: October 19, 2010
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation
Pradaxa Drug Information | Press Release
Date of Approval: October 16, 2010
Treatment for: Postoperative Ocular Inflammation
Bromday Drug Information | Press Release
Date of Approval: October 14, 2010
Treatment for: Primary Immunodeficiency Syndrome
Gamunex-C Drug Information | Press Release
Date of Approval: October 8, 2010
Treatment for: Osteoporosis
Atelvia Drug Information | Press Release
Date of Approval: October 7, 2010
Treatment for: Psoriasis
Sorilux Drug Information | Press Release
Date of Approval: October 5, 2010
Treatment for: Bronchial Challenge Test
Aridol Drug Information | Press Release
Date of Approval: September 28, 2010
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)
Kapvay 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 Indication Approved: October 28, 2010
Now Approved for: Newly Diagnosed Philadelphia Chromosome-positive (Ph+) Chronic Myeloid Leukemia
Sprycel Drug Information | Press Release
New Indication Approved: October 12, 2010
Now Approved for: Opioid-Dependence
Vivitrol Drug Information | Press Release
New Indication Approved: October 18, 2010
Now Approved for: Chronic Hepatitis B in Patients with Decompensated Liver Disease
Baraclude Drug Information | Press Release
New Indication Approved: October 20, 2010
Now Approved for: Metastatic Gastric Cancer
Herceptin Drug Information | Press Release
New Indication Approved: October 15, 2010
Now Approved for: Chronic Migraine
Botox Drug Information | Press Release
New Indication Approved: October 15, 2010
Now Approved for: Infantile Spasms
H.P. Acthar Gel 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.
Oxymorphone Hydrochloride Tablets
5 mg and 10 mg
Approved: September 27, 2010 - Roxane Laboratories, Inc.
Generic for: Opana
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for September 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
Arava
(leflunomide) tablets
x - x - - - - -
Zofran
(ondansetron hydrochloride) tablets, oral solution, orally disintegrating tablet, and injection
- x - x - - - -
Altabax 
(retapamulin) ointment
- - x x - - - -
Apokyn
(apomorphine hydrochloride) injection
- - x x - - - -
Casodex
(bicalutamide) tablet
- - x x - - - -
Combunox
(Oxycodone HCl/ibuprofen) tablets
- - x x - - - -
Desferal
(deferoxamine mesylate) injection
- - x - x - - -
Faslodex
(fulvestrant) solution for injection
- - x x - - - -
Minocin
(minocycline hydrochloride) pellet-filled capsules, intravenous, and oral suspension
- - x - x - - -
Noxafil
(posaconazole) oral suspension
- - x x x x - -
Rotarix
(rotavirus vaccine, live, oral) oral suspension
- - x x - - - -
Zegerid with Magnesium Hydroxide
(omeprazole/sodium bicarbonate/magnesium hydroxide) chewable tablets and tablets
- - x x - - - -
Cutivate
(fluticasone propionate) cream
- - - x x - - -
Cutivate
(fluticasone propionate) lotion
- - - x x - - -
Duetact
(pioglitazone HCl plus glimepiride) fixed-dose combination tablets
- - - x - - - -
Fazaclo
(clozapine) orally disintegrating tablets
- - - x x - - -
Lopid
(gemfibrozil) tablets
- - - x - - - -
Oraqix
(lidocaine and prilocaine periodontal) gel
- - - x - - - -
Ranexa
(ranolazine) extended-release tablets
- - - x - - - -
Welchol
(colsevelam) tablets and oral suspension
- - - x - - - -
Zyban 
(bupropion hydrochloride) sustained-release tablets
- - - x - - - -
Januvia
(sitagliptin) tablets
- - - - x - - -
Platinol and Platinol-AQ
(cisplatin) for injection
- - - - x - - -
Asmanex Twisthaler
(mometasone furoate) inhalation powder
- - - - - x - -
Pristiq
(desvenlafaxine succinate) extended-release tablets
- - - - - - - -
Zarontin
(ethosuxide) capsules
- - - - - - - -
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
Doctors Ordering Transfusions to Get Patients into Drug Trials
October 29, 2010
Canadian researchers say they've noticed a disturbing trend: Cancer doctors ordering unnecessary blood transfusions so that seriously ill patients can qualify for drug trials.
Concerns Grow Over Dangers of Caffeinated Alcohol Drinks
October 28, 2010
The debate over the dangers of alcoholic energy drinks, popular among the young because they are inexpensive and carry the added punch of caffeine, has intensified after students at colleges in New Jersey and Washington state became so intoxicated they wound up in the hospital.
Teens Should Get Meningitis Booster Shot: CDC Panel
October 27, 2010
Teenagers should get a booster shot of the vaccine that protects against bacterial meningitis, a United States health advisory has recommended.
Gene Mutations May Blunt Plavix's Effectiveness, Study Finds
October 26, 2010
People with certain gene variants who take the blood-thinning drug Plavix (clopidogrel) may be at increased risk for serious complications after coronary stent placement, a new study finds.
Ingredients in Red Yeast Rice Supplements Vary Widely: Study
October 26, 2010
There are widely inconsistent amounts of active ingredient in different formulations of popular red yeast rice supplements, a new study finds.
Heavy Smoking Linked to Alzheimer's in Study
October 25, 2010
Heavy smoking in middle age seems to increase the risk for developing Alzheimer's disease or another dementia, a large new study suggests.
Brain's Pleasure Chemical May Explain Men's Higher Alcoholism Rate
October 22, 2010
Differences in the release of the neurotransmitter dopamine may help explain why men are up to twice as likely as women to develop alcoholism, a new study says.
Peer Support May Bring Better Control of Diabetes
October 20, 2010
Pairing people with diabetes who are struggling to control their blood sugar levels with their peers for weekly support sessions could be an effective and inexpensive way to help manage the disease, researchers say.
Home Monitoring of Blood-Thinner Use Appears Effective
October 20, 2010
If you're taking the blood-thinning medication warfarin, a new study suggests that you might not always need to visit the doctor for medication level checking.
Binge Drinking, Pot Could Put Teens' Intellect at Risk: Study
October 19, 2010
Heavy alcohol and marijuana use puts teenagers at risk for mental deficits that could persist into adulthood, according to a new study.
Study Shows HRT Even Riskier Than Thought
October 19, 2010
Not only does prolonged use of hormone replacement therapy raise the risk of breast cancer, new research finds, but it also ups the risk for more severe forms of the disease and increases a woman's chances of dying.
Aspirin, Statins May Reduce Problems After Heart Surgery
October 19, 2010
Patients who took aspirin before heart surgery suffered fewer heart attacks, stroke and other problems after their operations, and those given statins had better survival rates, two new studies find.
Too Few Adults Vaccinated Against Whooping Cough: CDC
October 14, 2010
Recent outbreaks of whooping cough highlight the need for adults to be vaccinated against this highly contagious disease, say United States health officials.
Drug Implant for Opioid Addiction Looks Effective
October 12, 2010
Implanting the addiction-treatment drug buprenorphine in people who are opioid-dependent seems to reduce cravings in the short term, researchers say.
Cancer-Fighting Bone Drugs Might Raise Stroke Risk
October 12, 2010
A new study finds that cancer patients treated with bisphosphonate drugs such as Aredia or Zometa to reduce or delay bone complications from cancer may be at higher risk for the irregular heartbeat known as atrial fibrillation and for a related event, stroke.
Taking Blood Pressure Drugs at Bedtime May Boost Effectiveness
October 7, 2010
Taking blood-pressure pills at night, rather than in the morning, may better control hypertension and significantly reduce the risk of heart attack and stroke, new research suggests.
Many Americans Plan to Skip Flu Shot This Year
October 7, 2010
Although vaccination against influenza can protect people from illness and help prevent the spread of flu, many Americans say they and their children won't be getting a shot this coming season, new surveys reveal.
More Americans Drinking More Alcohol
October 6, 2010
Alcohol consumption is on the rise in the United States due to a number of factors, including social, economic and ethnic influences and pressures, a new study has found.
FDA MedWatch Alerts
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