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Featured News Novel Hepatitis C Drug Holds Promise: FDA
April 2011
An experimental new drug that may treat hepatitis C more effectively than earlier medications will be reviewed Thursday by a panel of experts for the U.S. Read more... New Drug Approvals
The following drugs have recently been approved by the FDA. Date of Approval: April 23, 2011 Treatment for: Osteoarthritis, Rheumatoid Arthritis, NSAID-Induced Ulcer Prophylaxis Duexis Drug Information | Press Release Date of Approval: April 11, 2011 Treatment for: Malignant Melanoma Sylatron Drug Information | Press Release Date of Approval: April 6, 2011 Treatment for: Restless Legs Syndrome Horizant Drug Information | Press Release Date of Approval: April 6, 2011
Treatment for: Thyroid Cancer vandetanib 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. Labeling Revision Approved: April 25, 2011 Now Approved for: Conversion to Monotherapy for Treatment of Partial Seizures Lamictal XR Drug Information | Press Release New Indication Approved: April 15, 2011 Now Approved for: Systemic Juvenile Idiopathic Arthritis Actemra Drug Information | Press Release New Indication Approved: April 19, 2011 Now Approved for: Wegener's Granulomatosis and Microscopic Polyangiitis Rituxan Drug Information | Press Release Patient Population Altered: April 6, 2011 Now Approved for: Schizophrenia in Adolescents 12 to 17 years Invega Drug Information | Press Release Patient Population Altered: April 22, 2011
Now Approved for: Prevention of Meningococcal Disease in Infants (9-23 months of age) Menactra 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, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, 0.25 mg/0.025 mg (28-Day Regimen) Approved: March 9, 2011 - Watson Laboratories, Inc. Generic for: Ortho Tri-Cyclen Lo Tablets Epinastine Hydrochloride Ophthalmic Solution
0.05% Approved: March 14, 2011 - Cypress Pharmaceutical, Inc. Generic for: Elestat Ophthalmic Solution FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for February 2011. Click on a drug name to view the changes in more detail.
Note: the drug safety labeling changes listed above may not be a complete list. Please visit the link below for the entire current list and historical archive.
Other Drug News
Many Kids With Epilepsy Don't Take Meds as Prescribed: Study April 26, 2011 Nearly three of every five children diagnosed with epilepsy do not take their antiseizure medicine as prescribed over the first six months of treatment, a new study shows.
Antidepressants Work Overall, But Some Symptoms May Persist April 26, 2011 Antidepressants may not improve all symptoms of depression, according to a new study.
Heart-Healthy Omega-3s Not Healthy for Prostate: Study April 25, 2011 High levels of heart-healthy omega-3 fatty acids in the blood may be associated with an increased risk for developing aggressive prostate cancer, while elevated levels of unhealthy trans-fatty acids may lower the risk, a new study suggests.
Common Painkillers May Blunt Antidepressants April 25, 2011 Common over-the-counter painkillers such as ibuprofen, aspirin and naproxen may reduce the effectiveness of antidepressants called selective serotonin reuptake inhibitors, or SSRIs, according to a mouse and human study from The Rockefeller University in New York City.
Experts Offer New Guidance for Blood Pressure Control in Elderly April 25, 2011 Elderly Americans are at high risk for high blood pressure and related health problems and death, but lifestyle changes and proper use of medicines can reduce these risks, says a clinical guidance statement released Monday by the American Heart Association and the American College of Cardiology.
Scientists Discover How Peppermint Soothes Gastric Pain April 22, 2011 New research offers insight into how peppermint helps relieve the symptoms of irritable bowel syndrome.
Newer 'Pill' Linked to Higher Risk of Blood Clots April 21, 2011 Newer forms of birth control pills may carry a higher risk of serious blood clots than earlier oral contraceptives.
Women Taking Calcium Supplements May Risk Heart Health, Researchers Say April 19, 2011 More evidence is emerging that women who take calcium supplements to prevent bone deterioration may, in fact, be risking their heart health.
Children With HIV at Higher Risk of Drug Resistance April 19, 2011 About 1 in 8 children infected with HIV experiences triple-class virological failure - meaning the virus becomes resistant to multiple drugs - within five years of starting antiretroviral treatment, a European study shows.
Most Parents Vaccinate Kids, Trust Docs' Advice on Shots April 19, 2011 About 93 percent of parents said their children either had or were going to get all of the recommended vaccinations, and more than three-fourths said they trusted their doctor's advice on immunizations, two new surveys find.
Alcohol-Energy Drink Combo Riskier Than Booze Alone, Study Says April 15, 2011 Combining the caffeine jolt of energy drinks with the intoxicating effects of alcohol is riskier than drinking alcohol alone, a new study suggests.
New Treatment for Urinary Tract Infections Called Promising April 15, 2011 Many women suffer from chronic urinary tract infections, but now a new treatment using a probiotic may provide lasting relief for some, a preliminary trial indicates.
Estrogen's Role in Breast Cancer Can Fluctuate April 15, 2011 Is estrogen breast cancer's friend or foe? A recent study in the Journal of the American Medical Association, which analyzed data from the massive Women's Health Initiative, suggested the latter when it found a reduced risk of breast cancer in women who had been on short-term estrogen therapy.
Use of Dietary Supplements Keeps Climbing: CDC April 13, 2011 More than half of American adults take dietary supplements, such as multivitamins and calcium, and their use jumped dramatically over a recent 20-year period, according to a new government report.
Fish Oil Promising Against Postpartum Depression in Small Trial April 12, 2011 Consuming omega-3 fatty acids in fish oil capsules during pregnancy may reduce a woman's risk of postpartum depression, according to a new study.
Extended HPV Vaccine Schedule Seems Effective April 12, 2011 Giving doses of human papillomavirus (HPV) vaccine over a longer-than-normal period of time may prove an effective way to make the vaccine available to more females in poorer nations, a new study suggests.
Drug Memantine Ineffective for Mild Alzheimer's, Study Finds April 11, 2011 A drug commonly prescribed for Alzheimer's disease, memantine (Namenda), appears to be ineffective in treating the mild stage of the disease, a new study finds.
Acne Antibiotics Not Linked to Drug Resistance April 11, 2011 Long-term use of antibiotics to treat acne doesn't seem to spur bacteria into becoming resistant to the medications, a new study finds.
Brain Tumor Vaccine Shows Promise in Early Trials April 11, 2011 A vaccine that jumpstarts the immune system is showing promise in keeping a deadly type of cancerous brain tumor at bay.
Certain Diabetes Drugs Better for Heart Health, Study Finds April 7, 2011 The commonly used oral diabetes drug metformin not only helps stabilize blood sugar levels, it also may offer protection against heart disease, researchers say.
Antibiotic-Resistant Bacteria in India Could Spread, Experts Say April 7, 2011 A gene that helps bacteria resist nearly all antibiotics is present in bacteria in public water supplies in New Delhi, India, researchers have found.
Two Different Heart Drugs May Work Equally Well for High-Risk Patients April 5, 2011 People with high blood pressure and impaired glucose tolerance seem to fare equally well when given two separate types of heart drugs, new research suggests.
Monthly Aspirin Use Linked to Lower Pancreatic Cancer Risk April 4, 2011 Taking aspirin even once per month, whether low-dose or full strength, appears to be associated with a marked drop in the risk of developing pancreatic cancer, new research reveals. |
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