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 NewsFDA News    May 16, 2008
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Breaking FDA News

FDA Says Roche Drug May Cause Miscarriages (CBS 46 News Atlanta)
The FDA says Roche and Novartis drugs prescribed to organ transplant patients can cause miscarriages and birth defects when used by pregnant women.
5/16/2008 6:37:21 PM

UDENT FDA News

Terguride Receives FDA Orphan Drug Designation for the Treatment of Pulmonary Arterial Hypertension

Ergonex Pharma today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to Terguride for the treatment of pulmonary arterial hypertension (PAH). Terguride is currently being evaluated for PAH in a pivotal Phase II trial in Europe.

5/15/2008 12:00:00 AM

FDA Approves AstraZeneca's Seroquel(R) for Maintenance Treatment in Bipolar Disorder

AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL(R) (quetiapine fumarate tablets) for the maintenance treatment of patients with bipolar I disorder, as adjunct therapy to lithium or divalproex.

5/14/2008 12:00:00 AM

FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis

 Warner Chilcott and LEO Pharma announced today that the United States Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Taclonex Scalp(R) (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension.

5/12/2008 12:00:00 AM

FDA Approves New Formulation of Coagulation Therapy

The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.

5/9/2008 12:00:00 AM

FDA Approves First Generic Ropinirole

The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

5/9/2008 12:00:00 AM

FDA Approves Strattera(R) for Maintenance of ADHD in Children and Adolescents

Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant to treat ADHD in children, adolescents and adults

5/8/2008 12:00:00 AM

FDA Approves Health Claim for Brown Rice

Brown rice, a 100 percent whole grain food, joins the recognized ranks of healthful whole grains, according to an announcement this week from the U.S.

5/8/2008 12:00:00 AM

FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products

The U.S. Food and Drug Administration’s final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula” has detected hazardous amounts of chromium.

5/1/2008 12:00:00 AM

FDA Embarks on Major Hiring Initiative for its Public Health Mission

Agency will fill more than 1,300 positions within the next several months

Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as the U.S. Food and Drug Administration begins a multi-year hiring initiative.

4/30/2008 12:00:00 AM

Coronary Artery Plaque Imaging Device Cleared by FDA

Plaque is a deposit made up of cholesterol-rich fat, calcium, and other substances found in the blood. As plaque accumulates on the artery wall, it reduces blood flow to the heart muscle and increases the risk of blood clots which can lead to a heart attack.

4/29/2008 12:00:00 AM

FDA Approves Relistor for Opioid-Induced Constipation

The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.

4/24/2008 12:00:00 AM

FDA Approves Cimzia to Treat Crohn's Disease

A new drug has been approved to help sufferers of Crohn's disease, the U.S. Food and Drug Administration announced today.

4/22/2008 12:00:00 AM

FDA Approves First Compact Heart Assist Device

The U.S. Food and Drug Administration today approved a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant.

4/21/2008 12:00:00 AM

Mylan Announces Final FDA Approval for Felodipine Extended-Release Tablets, USP

 Mylan Inc.today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Felodipine Extended-release Tablets USP, 2.5 mg, 5 mg and 10 mg.

4/21/2008 12:00:00 AM

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