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Vol 59 - July 2009
Featured News

Pregnant Women, Health-Care Workers Top Swine Flu Vaccine Candidates

July 2009
Women who are pregnant, children six months and older, and health care workers should all get top priority when the H1N1 swine flu vaccine arrives this fall, a United States government advisory panel has recommended. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Acuvail (ketorolac tromethamine) Ophthalmic Solution
Date of Approval: July 22, 2009
Treatment for: Postoperative Ocular Inflammation
Acuvail Drug Information | Press Release

Onsolis (fentanyl) Buccal Soluble Film
Date of Approval: July 16, 2009
Treatment for: Pain
Onsolis Drug Information | Press Release

Sumavel DosePro (sumatriptan) Injection
Date of Approval: July 15, 2009
Treatment for: Migraine, Cluster Headache
Sumavel DosePro Drug Information | Press Release

Plan B One-Step (levonorgestrel) Tablet
Date of Approval: July 10, 2009
Treatment for: Emergency Contraception
Plan B One-Step Drug Information | Press Release

Effient (prasugrel) Tablets
Date of Approval: July 10, 2009
Treatment for: Acute Coronary Syndrome
Effient Drug Information | Press Release

Multaq (dronedarone) Tablets
Date of Approval: July 1, 2009
Treatment for: Atrial Fibrillation, Atrial Flutter
Multaq Drug Information | Press Release

Feraheme (ferumoxytol) Intravenous Injection
Date of Approval: June 30, 2009
Treatment for: Anemia Associated with Chronic Renal Failure
Feraheme 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.

NovoLog (insulin aspart) Injection
Expiration Date Change Approved: July 14, 2009
Now Approved: Six Day Storage in Insulin Pumps
NovoLog Drug Information | Press Release

Forteo (teriparatide (rDNA origin)) Injection
New Indication Approved: July 22, 2009
Now Approved for: Glucocorticoid-Induced Osteoporosis
Forteo Drug Information | Press Release

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets
New Indication Approved: July 16, 2009
Now Approved for: Initial Therapy of Hypertension
Tekturna HCT 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.

Norgestimate and Ethinyl Estradiol Tablets
USP, 0.180 mg/0.025 mg; 0.215 mg/0.025 mg and 0.250 mg/0.025 mg (28-Day Regimen)
Approved: June 29, 2009 Barr Laboratories, Inc.
Generic for: Ortho Tri Cyclen Lo

Oxcarbazepine Oral Suspension
300 mg/5 mL
Approved: June 26, 2009 Ranbaxy Laboratories Limited
Generic for: Trileptal Oral Suspension

Levonorgestrel Tablets
(Rx) 0.75 mg
Approved: June 24, 2009 Watson Laboratories, Inc.
Generic for: Plan B (levonorgestrel) Tablets, 0.75 mg

Melphalan Hydrochloride for Injection
50 mg (base)/vial
Approved: June 9, 2009 Synerx Pharma, LLC
Generic for: Alkeran for Injection

Omeprazole Magnesium Delayed-Release Capsules
(OTC) 20 mg (base)
Approved: June 6, 2009 Dr. Reddy's Laboratories Limited
Generic for: Prilosec OTC Delayed-Release Capsules

Triamcinolone Acetonide Injectable Suspension
USP, 40 mg/mL; packaged in 40 mg/1 mL vials and 200 mg/5 mL and 400 mg/10 mL multiple-dose vials
Approved: June 1, 2009 Sandoz Canada Inc.
Generic for: Kenalog-40 Injectable Suspension

Other Drug News

Resistance to Malaria Drug Reported in Cambodia
July 29, 2009
Malaria parasites in western Cambodia have become resistant to artemisinin-based drugs, a development that could put millions of lives at risk, researchers say.

Older Diabetics Should Avoid Dementia Meds
July 28, 2009
Older diabetics who take antipsychotic medications have an increased risk of ending up in the hospital with elevated blood glucose levels, or hyperglycemia, researchers say.

More Can Be Done to Slow Obesity's Toll on Health: Experts
July 28, 2009
Obesity in the United States now carries the hefty price tag of $147 billion per year in direct medical costs, just over 9 percent of all medical spending, experts reported at a national conference Tuesday in Washington, DC.

Blue Dye Halts Worsening Paralysis in Animal Study
July 28, 2009
The food additive that makes M&Ms and Gatorade blue may help prevent the secondary damage that occurs after a spinal cord injury, a new study suggests.

Save Swine Flu Drugs for Younger Patients, Study Urges
July 28, 2009
Antiviral drug treatment of swine flu may be wasted on the elderly and should be reserved for young people, suggest researchers who created a model of the effect of antiviral treatment on the spread of the H1N1 virus.

Tight Management of Type 1 Diabetes Worth the Effort
July 27, 2009
By carefully controlling blood sugar levels and taking medications that lower blood pressure and cholesterol, people with type 1 diabetes can significantly reduce their risk of developing the most serious complications associated with the disease, new research shows.

Giving Statins to Kids Provokes Debate
July 26, 2009
Whether cholesterol-lowering drugs called statins should be given to children apparently depends on who you ask.

Breast Cancer Drug May Beat Fungal Infection
July 24, 2009
A drug used to help prevent recurring breast cancer appears to hold promise as a treatment for deadly fungal infections, new research has found.

Injection May Heal Damaged Heart
July 23, 2009
Doctors have been unable to help injured heart tissue renew itself after a heart attack - until now.

Many Young Adults Uninformed About Vaccines
July 22, 2009
Vaccines are not only for children, but many young adults in the United States are unaware of the need to keep up with their shots, a new survey shows.

No Firm Evidence Green Tea Helps Prevent Cancer
July 21, 2009
Does drinking green tea really help prevent cancer? The answer is still unclear, according to a review of 51 previous studies done over two decades.

High-Salt Diet Dampens Effects of Blood Pressure Drugs
July 20, 2009
Not only does a high-salt diet contribute to hypertension, but it can also reduce the effectiveness of blood pressure medications, a new study finds.

Internet May Be Newest Venue for Teen Tobacco Exposure
July 20, 2009
Even if you make sure your teen isn't watching TV shows or movies that glamorize smoking, he or she may still be getting positive tobacco messages via the Internet, particularly from popular social networking sites such as MySpace and Xanga.

Hopes Dashed for Thalidomide as Lung Cancer Treatment
July 16, 2009
Using the drug thalidomide in combination with chemotherapy won't improve survival for patients with small cell lung cancer but does increase their risk of blood clots, an English study finds.

Educated Parkinson's Patients Move to Meds Sooner
July 14, 2009
Parkinson's disease patients with higher levels of education or disability typically need treatment for their symptoms earlier than other patients, a new study finds.

'Easter Island' Drug Adds Years to Mice
July 8, 2009
Though researchers aren't ready to recommend that people start popping pills to live longer, they hope a drug used to prevent rejection of transplanted organs may turn out to extend lives, too.

Anti-Smoking Drugs Get FDA 'Black-Box' Warning
July 1, 2009
Two drugs prescribed to help people quit smoking, Chantix and Zyban, will now carry "black-box" warnings on the potential risks of psychiatric problems, including depression and suicidal thoughts, US health officials said.

More News Headlines

FDA MedWatch Alerts

Recall of Steam Dietary Supplement

FDA Advises Against Using Body Building Products Containing Steroids or Steroid-like Substances

FDA Warns Against Using Electronic Cigarettes

Voluntary Recall of Weight Loss Products by Young You Corporation

Recall of Teva's Propofol Injectable Emulsion, 10 mg/mL 100 mL vials

Voluntary Recall of Nature & Health Co. supplement products: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac

Voluntary Recall of Concentrated Acetaminophen Drops

FDA Requires Labeling Changes for Immunosuppressant Drugs

Voluntary Recall of Libipower Plus

Recall of Medtronic Paradigm Quick-Set Infusion Sets

Recall of Mallinckrodt Sodium Chromate Cr-51 Injection

Recall of Stealth Chocolate, Stealth Vanilla Powdered Dietary Supplement: Vital Pharmaceuticals Inc

FDA Warns of Overdose Risk with Propoxyphene-containing Products

FDA Reviewing Safety Data for Lantus (insulin glargine)

More FDA Medwatch Alerts

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