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Vol 68 - April 2010
Featured News

Record Number of Americans Got Flu Shots, CDC Says

April 2010
Apparently spurred by concerns about the recently discovered H1N1 swine flu virus, a record number of Americans - especially children and younger adults - got seasonal flu shots during the just-concluded flu season, health officials reported Thursday. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Provenge (sipuleucel-T) Suspension for Intravenous Infusion
Date of Approval: April 29, 2010
Treatment for: Prostate Cancer
Provenge Drug Information | Press Release

Zortress (everolimus) Tablets
Date of Approval: April 22, 2010
Treatment for: Organ Transplant -- Rejection Prophylaxis
Zortress Drug Information | Press Release

Oravig (miconazole) Buccal Tablets
Date of Approval: April 16, 2010
Treatment for: Oral Thrush
Oravig Drug Information | Press Release

Pancreaze (pancrelipase) Delayed-Release Capsules
Date of Approval: April 12, 2010
Treatment for: Pancreatic Exocrine Dysfunction
Pancreaze 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.

OxyContin (oxycodone) Controlled-Release Tablets
New Formulation Approved: April 5, 2010
Now Approved: New Formulation (to discourage misuse and abuse)
OxyContin Drug Information | Press Release

Tarceva (erlotinib) Tablets
New Indication Approved: April 16, 2010
Now Approved for: Maintenance Treatment of Advanced Non-Small Cell Lung Cancer
Tarceva 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.

Temozolomide Capsules 5 mg, 20 mg, 100 mg, 250 mg, 140 mg and 180 mg
Approved: March 1, 2010 Barr Pharmaceuticals, Inc.
Generic for: Temodar

Tamsulosin Hydrochloride Capsules 0.4 mg
Approved: March 2, 2010 Impax Laboratories, Inc.
Generic for: Flomax

Dactinomycin Injection 0.5 mg/vial
Approved: March 16, 2010 Bedford Laboratories
Generic for: Cosmegen

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets 180 mg / 240 mg
Approved: March 17, 2010 Company: Dr. Reddy's Laboratories Limited
Generic for: Allegra-D 24 Hour

Metaxalone Tablets 800 mg
Approved: March 31, 2010 Company: Sandoz Inc.
Generic for: Skelaxin

Other Drug News

Interrupting a Nurse Makes Medication Errors More Likely
April 26, 2010
Distracting an airline pilot during taxi, takeoff or landing could lead to a critical error - apparently the same is true of nurses who prepare and administer medication to hospital patients.

Four Unhealthy Behaviors Linked to Premature Death
April 26, 2010
A combination of four unhealthy behaviors - smoking, lack of exercise, poor diet and substantial alcohol consumption - greatly increases the risk of premature death, a new study has found.

Time to Remind Teens About Sun Protection
April 25, 2010
With summer fast approaching, it's time to remind teens about the importance of sun protection, dermatologists say.

Review Panel Leaves Controversial Lyme Disease Guidelines Unchanged
April 22, 2010
After more than a year of study, a specially appointed panel at the Infectious Diseases Society of America has decided that controversial guidelines for the treatment of Lyme disease are correct and need not be changed.

Flying With Needles and Meds Can Raise Security Flags
April 22, 2010
Adjusting to the necessary, but seemingly ever-changing security rules when traveling can be tough for anyone, but for someone traveling with a bagful of needles and vials of insulin or someone who's had a hip or knee replaced, the journey can be fraught with extra worry.

Supplements Might Reduce Breast Cancer Risk
April 18, 2010
Women who take multivitamin tablets along with calcium supplements seem to have a reduced risk of developing breast cancer, new research suggests.

Kids' Suicide Risk Same for All Antidepressants
April 12, 2010
There appears to be no difference among antidepressants in raising a kid's risk of suicidal thoughts, a new long-term study shows.

Prescriptions Translated to Spanish Could Be Hazardous to Health
April 8, 2010
Many Spanish-speaking people in the United States receive prescription instructions from the pharmacy so poorly translated that the medications are potentially hazardous to their health, a new study shows.

Chemicals in Beauty Products Tied to Early Puberty in Girls
April 8, 2010
Exposure to chemicals found in a wide range of consumer products may lead to delayed or early puberty in girls and increase their risk for health problems later in life, researchers say.

Insight on Herbals Eludes Doctors, Patients Alike
April 8, 2010
Medical personnel tend to think that people in general - themselves included - are poorly informed about herbal medicines and that their patients' faith in the power of such remedies is misplaced, according to a new survey.

Cancer Vaccines May Be On The Verge Of Wider Use
April 7, 2010
One of the persistent frustrations in cancer treatment has been the way that tumors can evade our immune systems as they grow and multiply inside our bodies.

Prescription Drug Abuse Sending More to Hospitals
April 6, 2010
Hospitalizations caused by accidental and intentional abuse of prescription sedatives, tranquilizers and other painkilling drugs has risen dramatically over the last decade, new research reveals.

Vaccines-By-Patch Good News for Needle-Phobic
April 5, 2010
Scientists say they've figured out how to vaccinate a person without using a needle, potentially giving the public one less excuse to avoid getting immunized.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

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