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Vol 57 - May 2009
Featured News

Most Americans Would Consider Splitting Pills to Save Money If Medicine Remains Safe and Effective, Survey Shows

May 2009
More than half of Americans said they would consider splitting their prescription pills to save money if their doctor said it would not be detrimental to their health, according to results of a national poll conducted by Opinion Research Corp. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Adcirca (tadalafil) Tablets
Date of Approval: May 22, 2009
Treatment for: Pulmonary Hypertension
Adcirca Drug Information | Press Release

Samsca (tolvaptan) Tablets
Date of Approval: May 19, 2009
Treatment for: Hyponatremia
Samsca Drug Information | Press Release

Fanapt (iloperidone) Tablets
Date of Approval: May 6, 2009
Treatment for: Schizophrenia
Fanapt Drug Information | Press Release

Cycloset (bromocriptine mesylate) Tablets
Date of Approval: May 5, 2009
Treatment for: Diabetes Mellitus Type II
Cycloset Drug Information | Press Release

Creon (pancrelipase) Delayed-Release Capsules
Date of Approval: April 30, 2009
Treatment for: Pancreatic Exocrine Dysfunction
Creon Drug Information | Press Release

Cetraxal (ciprofloxacin otic) Solution
Date of Approval: May 1, 2009
Treatment for: Otitis Externa
Cetraxal Drug Information | Press Release

Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets
Date of Approval: April 30, 2009
Treatment for: Hypertension
Exforge HCT Drug Information | Press Release

Dysport (abobotulinumtoxinA)
Date of Approval: April 30, 2009
Treatment for: Cervical Dystonia, Glabellar Lines
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.

Prevacid (lansoprazole)
New Dosage Form Approved: May 13, 2009
Now Approved: Prevacid 24HR (OTC)
Prevacid Drug Information | Press Release

ACTOplus met (pioglitazone and metformin) Tablets
New Dosage Form Approved: May 12, 2009
Now Approved: ACTOplus met XR
ACTOplus met Drug Information | Press Release

Lamictal (lamotrigine)
New Dosage Form Approved: May 8, 2009
Now Approved: Lamictal ODT Orally Disintegrating Tablets
Lamictal Drug Information | Press Release

Risperdal (risperidone)
New Indication Approved: May 15, 2009
Now Approved: Risperdal Consta for Bipolar I Disorder
Risperdal Drug Information | Press Release

Cimzia (certolizumab pegol) Injection
New Indication Approved: May 13, 2009
Now Approved for: Rheumatoid Arthritis
Cimzia Drug Information | Press Release

Azor (amlodipine and olmesartan) Tablets
New Indication Approved: May 11, 2009
Now Approved for: First-Line Treatment for High Blood Pressure
Azor Drug Information | Press Release

Avastin (bevacizumab) Injection
New Indication Approved: May 5, 2009
Now Approved for: Glioblastoma
Avastin 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.

Risperidone Orally Disintegrating Tablets
0.25 mg, 0.5 mg, 2 mg, 3 mg and 4 mg
Approved: April 30, 2009 Kali Laboratories, Inc.
Generic for: Risperdal-M Tab (Orally Disintegrating Tablet)

Mivacurium Chloride Injection
2 mg (base)/mL; packaged in 10 mg (base)/5 mL and 20 mg (base)/10 mL single-dose vials
Approved: April 30, 2009 Ebewe Parenta Pharmaceuticals, Inc.
Generic for: Mivacron Injection

Azelastine Hydrochloride Nasal Solution (Nasal Spray)
0.1% [125 mcg (base)/spray]
Approved: April 30, 2009 Apotex Inc.
Generic for: Astelin Nasal Spray

Lorazepam Oral Concentrate
USP 2 mg/mL
Approved: April 28, 2009 Paddock Laboratories, Inc.
Generic for: Lorazepam Intensol

Topiramate Capsules (Sprinkle)
15 mg and 25 mg
Approved: April 15, 2009 Cobalt Laboratories, Inc.; Barr Laboratories, Inc.
Generic for: Topamax Sprinkle Capsules

Other Drug News

Parents Often Puzzled by Medicine Labels
May 26, 2009
The labeling on children's over-the-counter cold medicines can be confusing to parents, a new study has found.

Health Tip: Drugs That May Lead to Diarrhea
May 20, 2009
Certain medications are more likely than others to aggravate the digestive tract and result in loose stools, the United States National Library of Medicine says.

Study Reiterates Eye Risks Linked to Flomax
May 19, 2009
Men taking Flomax to treat an enlarged prostate face more than double the risk for serious complications should they need cataract surgery, a new Canadian study has found.

Pills Plus Psychotherapy Can Beat Insomnia
May 19, 2009
If you've been having trouble falling asleep or staying asleep, a new study suggests that the short-term use of sleep medications plus behavioral changes may be the best combination for getting your zzz's.

Multivitamins Might Prolong Life
May 18, 2009
Multivitamins may help women live longer by preventing parts of their DNA from shortening, a new study has found.

Chewable Aspirin More Readily Absorbed
May 15, 2009
Chewable aspirin is more readily absorbed into the bloodstream, making it the best aspirin choice for people suffering a cardiac incident, University of California, San Diego researchers report.

Ginger Eases Nausea From Chemo
May 14, 2009
Researchers have discovered the nausea-easing powers of ginger that many grandmothers are already familiar with, and report that the spice helped cancer patients who were undergoing chemotherapy.

Before Conceiving, Take Folic Acid for One Full Year
May 12, 2009
When taken for at least a year before conception, folic acid supplements can help reduce the chance of a premature birth by at least 50 percent, University of Texas researchers say.

Health Tip: Manage Medications Safely
May 8, 2009
To avoid the possibility of overdose, interaction or reaction, you must pay attention to how often, how and which medications you take.

All Blood Pressure Drugs Lower Risk of Heart Attack and Stroke
May 7, 2009
Lowering blood pressure is essential for reducing the risk of heart disease and stroke, but which drugs are best has been a matter of debate.

Plavix, Heartburn Drugs May Be Risky Combination
May 6, 2009
Anyone who takes the clot-preventing drug Plavix after receiving a stent in a coronary artery-opening procedure should avoid popular heartburn medications called proton pump inhibitors (PPIs), if possible, a group of heart experts now say.

Testosterone Injections Offer Hope for Male Contraceptive
May 5, 2009
Injectable testosterone may be an effective form of male contraception, new research suggests.

Smoking Packs a Tougher Wallop for Women
May 4, 2009
Women may be more vulnerable than men to cancer-causing ingredients in cigarettes, according to a new study.

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