 |
|
Featured News Monthly News Round Up - September 2012
September 2012
Stivarga Approved Under FDA Priority Review The second new treatment in two months has been approved for the treatment of adults with metastatic colorectal cancer. Read more... New Drug Approvals
The following drugs have recently been approved by the FDA. Date of Approval: September 27, 2012 Treatment for: Colorectal Cancer Stivarga Drug Information | Press Release Date of Approval: September 12, 2012 Treatment for: Multiple Sclerosis Aubagio Drug Information | Press Release Date of Approval: September 4, 2012
Treatment for: Chronic Myelogenous Leukemia Bosulif 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. New Formulation Approved: August 31, 2012 Now Approved: Exelon Patch 13.3 mg/24 hours Exelon Drug Information | Press Release New Indication Approved: September 21, 2012 Now Approved for: Increasing Bone Mass in Men with Osteoporosis Prolia Drug Information | Press Release New Indication Approved: September 28, 2012
Now Approved for: Ulcerative Colitis Humira 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.
Valsartan and Hydrochlorothiazide Tablets USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg Approved: September 21, 2012 - Mylan Pharmaceuticals Inc. Generic for: Diovan HCT Aprepitant Capsules 40 mg, 80 mg and 125 mg Approved: September 24, 2012 - Sandoz Inc. Generic for: Emend Tolterodine Tartrate Tablets 1 mg and 2 mg Approved: September 25, 2012 - Apotex Corp. Generic for: Detrol Amlodipine Besylate, Hydrochlorothiazide and Valsartan Tablets
5 mg/12.5 mg/160 mg, 10 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg Approved: September 25, 2012 - Teva Pharmaceuticals USA Inc. Generic for: Exforge HCT FDA Drug Safety Labeling Changes
This is a summary of the FDA drug labeling changes for July 2012. 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
Flu Season's Approaching So Roll Up Your Sleeve September 27, 2012 The only thing predictable about the flu is its unpredictability, health officials said Thursday, as they urged virtually all Americans to get vaccinated for the coming season.
Prescription Drug Abuse Drops Among U.S. Young Adults September 24, 2012 Prescription drug abuse among young adults ages 18 to 25 in the United States fell 14 percent between 2010 and 2011, according to a federal report released Monday.
Survival After General Anesthesia Vastly Improved: Study September 20, 2012 The number of people who survive surgery when general anesthesia is used has improved dramatically over the past 50 years, Canadian researchers report.
FDA Warns Against Use of Diarrhea Drug From El Salvador September 19, 2012 Consumers should not use a drug product called Intestinomicina - marketed as a treatment for infectious diarrhea and acute gastrointestinal infections - because it contains an ingredient that can cause serious and potentially deadly problems, the United States Food and Drug Administration warns.
More U.S. Kids Prescribed Off-Label Antipsychotics: Study September 18, 2012 Over the past decade, off-label use of antipsychotic drugs has increased among children enrolled in Medicaid, according to a new study representing 35 percent of children in the United States.
Study Assesses Blood Thinner Use After Gastrointestinal Bleeding September 17, 2012 New research suggests that people who stop taking the blood thinner warfarin (Coumadin) because of gastrointestinal bleeding raise their risk of blood clots and death if they stay off the drug.
Whooping Cough Vaccine Protection Fades Over Time: Study September 12, 2012 While the whooping cough vaccine offers the best chance of protection against this potentially deadly disease, immunity provided by the vaccine appears to wane significantly every year after vaccination.
'Superpowered' Bacteria May Lurk Behind Sinus Infections September 12, 2012 A small new study offers insight into the germ warfare that goes on inside the heads of people with chronic sinus infections.
Omega-3s May Not Help Your Heart After All, Study Says September 11, 2012 Omega-3 fatty acids have been touted as a way to reduce the risk of a host of cardiovascular problems, but now Greek researchers report that may not be true.
When Prescription Drugs Go OTC, Ads Talk Less of Harms: Study September 11, 2012 When prescription drugs become available over-the-counter, advertisements for the medications are far less likely to tell consumers about the potential harms and side effects, new research finds.
Common Painkillers Might Boost Odds for Second Heart Attack September 10, 2012 People who've already suffered a heart attack may face higher odds of death or subsequent heart attack if they regularly take a common form of painkiller, Danish researchers report.
New Strep Throat Guidelines Tackle Antibiotic Resistance September 10, 2012 Doctors need to accurately diagnose and treat strep throat in order to avoid inappropriate use of antibiotics that can lead to drug-resistant bacteria, according to updated guidelines from the Infectious Diseases Society of America.
Pediatricians' Group Urges Flu Shot for Kids Aged 6 Months and Up September 10, 2012 The leading pediatricians' group in the United States is again urging parents to get all children aged 6 months or over immunized in preparation for the coming flu season.
Newer Rheumatoid Arthritis Drugs Don't Raise Cancer Risk: Study September 6, 2012 A new review finds that rheumatoid arthritis medications known as biologics don't raise the risk of cancer, contrary to what some previous research has suggested.
Ginkgo Won't Prevent Alzheimer's, Study Finds September 5, 2012 Yet another study, this one by French researchers, finds that the herbal supplement ginkgo biloba won't prevent or delay Alzheimer's disease. |
FDA MedWatch Alerts
 Tools & Helpful Links
Community Discussion Forums
We welcome you to share your experiences. Medical Encyclopedia
Use this feature to find information on diseases, symptoms, injuries, medical tests and surgical procedures. Browse by Medical Condition
Use this feature to find drugs or medication related to a condition or therapeutic group. Pill Identifier
The Pill Identifier enables a search for unidentified pills by imprint code or shape/color. Drug Interactions Checker
Increasingly popular as more healthcare professionals and consumers make the effort to seek detailed information on drug-drug and drug-food interactions. New Drugs
All the latest information on FDA Approvals and recent additions to the database. News & Articles
Roundup of recent drug-related news and press releases. also latest news from FDA Medwatch service including timely publication of recalls, withdrawals, warnings, and label/packaging changes. About This Newsletter
Drugs.com is not affiliated with any pharmaceutical company. We are dedicated to providing consumers and health professionals with objective information about prescription-medication discoveries and side effects.
This information is not intended to be medical advice. You should contact your physician before making any changes to your health care. Drugs.com is not responsible for content provided by third-party websites.
About Your Subscription
You received this email because you are subscribed to updates from Drugs.com. Change your notification settings or unsubscribe here.
Your Feedback
We always appreciate feedback so if you wish to give us your comments/ praise/ rebuke please Contact Us.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Your Privacy - Any personal information you provide to us will only be used to notify you of offers, information and activities.
We'll hold the information about you securely and will not disclose it except for this purpose, or when required by law. Copyright © 2012 Drugs.com. All Rights Reserved. You received this email because you are subscribed to updates from Drugs.com. Change your notification settings or unsubscribe here. |