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Newsletter
Vol 73 - September 2010
Featured News
Medicines Pose Greater Threat to Kids Than Chemicals
September 2010
Most parents these days are mindful of obvious poisoning risks to their children. Read more...
New Drug Approvals
The following drugs have recently been approved by the FDA.
Date of Approval: September 24, 2010
Treatment for: Contraception, Premenstrual Dysphoric Disorder, Acne
Beyaz Drug Information | Press Release
Date of Approval: September 21, 2010
Treatment for: Multiple Sclerosis
Gilenya Drug Information | Press Release
Date of Approval: September 14, 2010
Treatment for: Gout
Krystexxa 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: September 9, 2010
Now Approved: 500 mg Injection
Faslodex Drug Information | Press Release
New Indication Approved: September 24, 2010
Now Approved for: Non-Infectious Uveitis
Ozurdex Drug Information | Press Release
Patient Population Altered: September 8, 2010
Now Approved for: Pediatric Patients
Protopam Chloride 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.
Norethindrone and Ethinyl Estradiol Tablets (Chewable), and Ferrous Fumarate Tablets, (Chewable)
0.4 mg/0.035 mg/75 mg (28-Day Regimen)
Approved: August 5, 2010 - Barr Laboratories, Inc.
Generic for: Femcon Fe
Trospium Chloride Tablets
20 mg
Approved: August 13, 2010 - Glenmark Generics Ltd.
Generic for: Sanctura
Atomoxetine Hydrochloride Capsules
10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg
Approved: August 30, 2010 - Actavis Elizabeth LLC; Sun Pharma Global; Mylan Pharmaceuticals, Inc.
Generic for: Strattera
FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for August 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
Biltricide
(praziquantel) tablets
- x x x x - - -
Meridia
(sibutramine hydrochloride) capsules
- x x x - - - -
Atripla
(efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets
- - x x x x - -
Childrens Advil Cold
(ibuprofen 100mg and pseudoephedrine 15 mg/5 mL) oral suspension
- - x - - - - -
Cubicin
(daptomycin) for injection
- - x - x - - -
Exelon Patch
(rivastigmine) transdermal system
- - x x x - - -
Flagyl
(metronidazole) tablets, capsules, and Flagyl ER tablets
- - x - x - - -
Heparin Sodium in the 5% Dextrose injection and in the 0.9% Sodium Chloride injection
- - x - - - - -
Plavix
(clopidogrel bisulfate) tablets
- - x x - - - -
Risperdal
(risperidone) tablets, Risperdal (risperidone) oral solution, and Risperdal M-Tab (risperidone) oral disintegrating tablets
- - x x x - - -
Augmentin XR
(amoxicillin/clavulanate potassium) extended release tablets
- - - x - - - -
Imitrex
(sumatriptan) tablets
- - - x - - - -
Taxol
(paclitaxel) for injection
- - - x x - - -
Zomig
(zolmitriptan) tablets and orally disintegrating tablets
- - - x - - - -
Lupron Depot - Ped
(leuprolide acetate for depot suspension) Injection, Powder for Suspension
- - - - x - - -
Risperdal Consta
(risperidone) long-acting injection
- - - - x - - -
Valturna
(aliskiren/valsartan) combination tablets
- - - - x - - -
Xalatan
(latanoprost) ophthalmic solution
- - - - x - - -
Zithromax
(azithromycin) tablet, single-dose packet, IV for injection, and oral suspension
- - - - x - - -
Other Drug News
As Science Unlocks Secrets, Cancer Rates Fall
September 24, 2010
Cancer is one of the most feared diseases on the planet, and the second leading cause of death in the United States.
Over 3,400 sites join DEA Nationwide Effort to Take-Back Prescription Drugs On Sept 25
September 16, 2010
Less than a month into the Drug Enforcement Administration'’s prescription drug "Take-Back" campaign, over 3,400 sites nationwide have joined the effort that seeks to prevent increased pill abuse and theft.
Use of Marijuana, Ecstasy, Methamphetamine on Rise in U.S.
September 16, 2010
Illegal drug use in the United States increased from 2008 to 2009, federal drug officials reported, citing growing acceptance of marijuana and an upswing in ecstasy and methamphetamine use.
Childhood Vaccination Rates Remain High in U.S.
September 16, 2010
U.S. childhood immunization rates remain high, with coverage for most routine vaccines at or over 90 percent, a new federal report shows.
Helping Smokers Quit Could Save U.S. Money: Report
September 15, 2010
Proven smoking cessation treatments save money as well as lives, according to a new study.
Expert Panel Links Popular Bone Drugs to Rare Fracture
September 14, 2010
An expert panel concludes that bone-strengthening bisphosphonate drugs such as Actonel, Boniva and Fosamax can actually raise risks for a rare type of fracture of the thighbone.
Smokeless Tobacco Products Can Be Deadly
September 13, 2010
Smokeless tobacco products, such as chewing tobacco and snuff, are not safe or effective alternatives for people who want to quit smoking, says a policy statement released Monday by the American Heart Association.
More Evidence That Vaccines Don't Cause Autism
September 13, 2010
Infants exposed to the highest levels of thimerosal, a mercury-laden preservative that used to be found in many vaccines, were no more likely to develop autism than infants exposed to only a little thimerosal, new research finds.
Substance Abuse Admissions Double Among Older Adults
September 9, 2010
The number of people aged 50 and older admitted for substance abuse treatment in the United States has more than doubled since the early 1990s, says a federal government study.
Proximity Affects Influence of Online 'Health Buddies'
September 2, 2010
When it comes to online social networking, people are more likely to change habits that might affect their health when encouraged to do so by cyber conversations with friends they already know well and with whom they are in close contact, new research suggests.
Prescription Drug Use Rising in U.S., CDC Reports
September 2, 2010
Over the last 10 years, the percentage of Americans who took at least one prescription drug in the past month increased from 44 percent to 48 percent, says a federal government study.
Study Identifies Risks for Painkiller Addiction
September 2, 2010
The mystery of why some people are more likely to become addicted to opioid painkillers has been partially unraveled by the Geisinger Health System in Pennsylvania.
Diabetes Drug Metformin Linked to Lower Lung Cancer Rate in Mice
September 1, 2010
A drug widely used to treat high blood sugar in type 2 diabetics may hold some promise in the prevention of tobacco-induced lung cancer, according to extremely preliminary findings in a mouse study.
FDA MedWatch Alerts
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