Drugs.com Newsletter Vol 86 - October 2011 RSS News Feeds: http://www.drugs.com/rss.html You received this email because you are subscribed to updates from Drugs.com Change your notification settings or unsubscribe here: http://www.drugs.com/my_subscriptions.php?email=%PERS_EMAIL%&pid=%PERS_ID% FEATURED NEWS ------------- Monthly Roundup - October 2011 October 2011 - Non-Opioid Exparel Approved for Post-Surgical Pain Relief Exparel (bupivacaine liposome injectable suspension), a non-opioid local anesthetic agent, has received FDA-approval for post-surgical pain relief Read more: http://www.drugs.com/news/monthly-roundup-october-2011-34584.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Exparel (bupivacaine) Injectable Suspension http://www.drugs.com/exparel.html Date of Approval: October 28, 2011 Treatment for: Pain Exparel Drug Information: http://www.drugs.com/exparel.html Press Release: http://www.drugs.com/newdrugs/pacira-pharmaceuticals-inc-announces-u-s-fda-approval-exparel-postsurgical-pain-management-2938.html Onfi (clobazam) Tablets http://www.drugs.com/onfi.html Date of Approval: October 21, 2011 Treatment for: Lennox-Gastaut Syndrome Onfi Drug Information: http://www.drugs.com/onfi.html Press Release: http://www.drugs.com/newdrugs/fda-approves-onfi-seizures-associated-lennox-gastaut-syndrome-2921.html Ferriprox (deferiprone) Tablets http://www.drugs.com/ferriprox.html Date of Approval: October 14, 2011 Treatment for: Hemosiderosis Ferriprox Drug Information: http://www.drugs.com/ferriprox.html Press Release: http://www.drugs.com/newdrugs/fda-approves-ferriprox-patients-excess-iron-body-2896.html Juvisync (simvastatin and sitagliptin) Tablets http://www.drugs.com/juvisync.html Date of Approval: October 7, 2011 Treatment for: Diabetes Mellitus Type II, Homozygous Familial Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia, Hypertriglyceridemia Juvisync Drug Information: http://www.drugs.com/juvisync.html Press Release: http://www.drugs.com/newdrugs/fda-approves-combination-therapy-juvisync-2894.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Combivent (albuterol and ipratropium) Inhalation Aerosol http://www.drugs.com/combivent.html New Formulation Approved: October 7, 2011 Now Approved: Combivent Respimat Combivent Drug Information: http://www.drugs.com/combivent.html Press Release: http://www.drugs.com/newdrugs/fda-approves-combivent-respimat-ipratropium-bromide-albuterol-inhalation-patients-chronic-2895.html Cialis (tadalafil) Tablets http://www.drugs.com/cialis.html New Indication Approved: October 7, 2011 Now Approved for: Benign Prostatic Hyperplasia Cialis Drug Information: http://www.drugs.com/cialis.html Press Release: http://www.drugs.com/newdrugs/fda-approves-cialis-benign-prostatic-hyperplasia-2890.html 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. Levetiracetam Extended-Release Tablets 500 mg and 750 mg Approved: September 12, 2011 - Actavis Elizabeth LLC; Par Pharmaceutical, Inc.; Apotex, Watson Laboratories, Inc.; Mutual Pharmaceutical Company, Inc.; Teva Pharmaceuticals USA Generic for: Keppra XR Felbamate Tablets 400 mg and 600 mg Approved: September 13, 2011 - Amneal Pharmaceuticals Generic for: Felbatol Tablets Doxercalciferol Capsules 0.5 mcg Approved: September 23, 2011 - Roxane Laboratories, Inc. Generic for: Hectorol Capsules Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Experimental Psoriasis Drug Bests Older Treatment http://www.drugs.com/news/experimental-psoriasis-bests-older-34495.html Newer 'Pill' May Raise Blood Clot Risk http://www.drugs.com/news/newer-pill-may-raise-blood-clot-risk-34486.html Some Asthma Drugs Raise Risk of Complications, Especially in Kids: Study http://www.drugs.com/news/some-asthma-raise-risk-complications-especially-kids-study-34451.html Taking Blood Pressure Meds at Bedtime May Be Better http://www.drugs.com/news/blood-pressure-meds-bedtime-may-better-34425.html Experimental Vaccine Shows Promise for Lung Cancer: Study http://www.drugs.com/news/experimental-vaccine-shows-promise-lung-cancer-study-34420.html Femara May Beat Tamoxifen at Preventing Breast Cancer's Return http://www.drugs.com/news/femara-may-beat-tamoxifen-preventing-breast-cancer-s-return-34383.html Antidepressant Use Skyrocketed in Past 20 Years: CDC http://www.drugs.com/news/antidepressant-skyrocketed-past-20-years-cdc-34336.html Promising Malaria Vaccine May Save Children's Lives http://www.drugs.com/news/promising-malaria-vaccine-may-save-children-s-lives-34316.html Hormonal Treatment of Hot Flashes Still OK for Some: Experts http://www.drugs.com/news/hormonal-hot-flashes-still-ok-some-experts-34314.html New ADHD Guidelines Include Preschoolers, Older Teens http://www.drugs.com/news/new-adhd-guidelines-include-preschoolers-older-teens-34272.html Genetic Profiling Adds New Dimension to Breast Cancer Treatment http://www.drugs.com/news/genetic-profiling-adds-new-dimension-breast-cancer-34255.html New Alzheimer's Drug Shows Early Promise http://www.drugs.com/news/new-alzheimer-s-shows-early-promise-34161.html Drug Combo Might Fight Aggressive Breast Cancer More Safely http://www.drugs.com/news/combo-might-fight-aggressive-breast-cancer-more-safely-34070.html Experimental MS Drug Shows Promise http://www.drugs.com/news/experimental-ms-shows-promise-34071.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots http://www.drugs.com/fda/birth-control-pills-containing-drospirenone-possible-increased-risk-blood-clots-13040.html Market Withdrawal: Xigris [drotrecogin alfa (activated)] - Failure to Show Survival Benefit http://www.drugs.com/fda/xigris-drotrecogin-alfa-activated-market-failure-show-survival-benefit-13039.html Chantix (varenicline) http://www.drugs.com/fda/chantix-varenicline-13038.html Drug Safety Communication Update: Zyvox (linezolid) - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications http://www.drugs.com/fda/zyvox-linezolid-safety-communication-serious-cns-reactions-possible-given-patients-certain-13035.html Drug Safety Communication Update: Methylene Blue - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications http://www.drugs.com/fda/methylene-blue-safety-communication-serious-cns-reactions-possible-given-patients-certain-13036.html Recall: Nostrilla Nasal Decongestant - Bacterial Contamination http://www.drugs.com/fda/nostrilla-nasal-decongestant-recall-bacterial-contamination-13037.html Drug Safety Communication: Sprycel (dasatinib) - Risk of Pulmonary Arterial Hypertension http://www.drugs.com/fda/sprycel-dasatinib-safety-communication-risk-pulmonary-arterial-hypertension-13033.html Recall: Uprizing 2.0 - Undeclared Drug Ingredient - Synthetic Steroid http://www.drugs.com/fda/uprizing-2-0-recall-undeclared-ingredient-synthetic-steroid-13032.html H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination http://www.drugs.com/fda/h-p-industries-povidone-iodine-prep-pads-recall-potential-microbial-contamination-13030.html More FDA Medwatch Alerts: http://www.drugs.com/fda_alerts.html TOOLS & HELPFUL LINKS --------------------- Community Discussion Forums - We welcome you to share your experiences. http://www.drugs.com/forum/ Medical Encyclopedia - Use this feature to find information on diseases, symptoms, injuries, medical tests and surgical procedures. http://www.drugs.com/enc/ Browse by Medical Condition - Use this feature to find drugs or medication related to a condition or therapeutic group. http://www.drugs.com/medical_conditions.html Pill Identifier - The Pill Identifier enables a search for unidentified pills by imprint code or shape/color. http://www.drugs.com/pill_identification.html 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. http://www.drugs.com/drug_interactions.html New Drugs - All the latest information on FDA Approvals and recent additions to the database. http://www.drugs.com/newdrugs.html 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. http://www.drugs.com/news.html ABOUT THIS NEWSLETTER --------------------- Drugs.com is not affiliated with any pharmaceutical company. 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