Drugs.com Newsletter Vol 87 - November 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 - November 2011 November 2011 - Intermezzo Approved for Middle of Night Insomnia Intermezzo (zolpidem tartrate), a low-dose, sublingual form of zolpidem tartrate, was FDA-approved for insomnia associated with middle-of-the night awakenings Read more: http://www.drugs.com/news/monthly-roundup-november-2011-35121.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Intermezzo (zolpidem tartrate) Sublingual Tablets http://www.drugs.com/intermezzo.html Date of Approval: November 23, 2011 Treatment for: Insomnia Intermezzo Drug Information: http://www.drugs.com/intermezzo.html Press Release: http://www.drugs.com/newdrugs/fda-approves-intermezzo-middle-night-waking-followed-difficulty-returning-sleep-2962.html Erwinaze (asparaginase Erwinia chrysanthemi) Injection http://www.drugs.com/erwinaze.html Date of Approval: November 18, 2011 Treatment for: Acute Lymphoblastic Leukemia Erwinaze Drug Information: http://www.drugs.com/erwinaze.html Press Release: http://www.drugs.com/newdrugs/fda-approves-erwinaze-acute-lymphoblastic-leukemia-2954.html Eylea (aflibercept) Injection http://www.drugs.com/eylea.html Date of Approval: November 18, 2011 Treatment for: Macular Degeneration Eylea Drug Information: http://www.drugs.com/eylea.html Press Release: http://www.drugs.com/newdrugs/fda-approves-eylea-wet-age-related-macular-degeneration-2955.html Jakafi (ruxolitinib) Tablets http://www.drugs.com/jakafi.html Date of Approval: November 16, 2011 Treatment for: Myelofibrosis Jakafi Drug Information: http://www.drugs.com/jakafi.html Press Release: http://www.drugs.com/newdrugs/fda-approves-jakafi-myelofibrosis-2949.html Forfivo XL (bupropion hydrochloride) Extended Release Tablets http://www.drugs.com/forfivo-xl.html Date of Approval: November 10, 2011 Treatment for: Depression Forfivo XL Drug Information: http://www.drugs.com/forfivo-xl.html Press Release: http://www.drugs.com/newdrugs/intelgenx-announces-fda-approval-anti-depressant-forfivo-xl-2991.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Xarelto (rivaroxaban) Tablets http://www.drugs.com/xarelto.html New Indication Approved: November 4, 2011 Now Approved for: Prevention of Thromboembolism in Atrial Fibrillation Xarelto Drug Information: http://www.drugs.com/xarelto.html Press Release: http://www.drugs.com/newdrugs/fda-approves-xarelto-prevent-stroke-common-type-abnormal-heart-rhythm-2942.html Erbitux (cetuximab) Injection http://www.drugs.com/erbitux.html New Indication Approved: November 7, 2011 Now Approved for: Late-Stage Head and Neck Cancer Erbitux Drug Information: http://www.drugs.com/erbitux.html Press Release: http://www.drugs.com/newdrugs/fda-approves-erbitux-late-stage-head-neck-cancer-2943.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.Fluocinolone Acetonide Otic Oil 0.01% Approved: October 17, 2011 - Identi Pharmaceuticals Inc. Generic for: DermOtic OilFluocinolone Acetonide Topical Oil 0.01% Approved: October 17, 2011 - Identi Pharmaceuticals Inc. Generic for: Derma-Smoothe/FS Scalp OilFluocinolone Acetonide Topical Oil 0.01% Approved: October 17, 2011 - Identi Pharmaceuticals Inc. Generic for: Derma-Smoothe/FS Body OilOlanzapine Tablets 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg Approved: October 24, 2011 - Teva Pharmaceuticals USA Generic for: ZyprexaOlanzapine Tablets 20 mg Approved: October 24, 2011 - Dr. Reddy's Laboratories Ltd. Generic for: ZyprexaOlanzapine Intramuscular Injection 10 mg/vial Approved: October 24, 2011 - InnoPharma LLC Generic for: Zyprexa Injection Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Newer Blood Thinner May Pose Danger to Trauma Patients http://www.drugs.com/news/newer-blood-thinner-may-pose-danger-trauma-patients-35032.html Four Common Meds Send Thousands of Seniors to Hospital: CDC http://www.drugs.com/news/four-common-meds-send-thousands-seniors-hospital-cdc-35033.html Cholesterol-Lowering Drugs Safe for Long-Term Use, Study Finds http://www.drugs.com/news/cholesterol-lowering-safe-long-term-study-finds-35010.html Too Much Acetaminophen Over Time May Damage Liver http://www.drugs.com/news/much-acetaminophen-over-time-may-damage-liver-35009.html Cholesterol Drug Shows Promise in Early Research http://www.drugs.com/news/cholesterol-shows-promise-early-research-34861.html Could Women's Use of 'the Pill' Raise Men's Prostate Cancer Risk? http://www.drugs.com/news/could-women-s-pill-raise-men-s-prostate-cancer-risk-34856.html Experimental Drug for Irregular Heart Rhythm Raises Death Risk: Study http://www.drugs.com/news/experimental-irregular-heart-rhythm-raises-death-risk-study-34848.html More Teens Getting Vaccines Against HPV, Other Infections: CDC http://www.drugs.com/news/more-teens-getting-vaccines-against-hpv-other-infections-cdc-34845.html Shot Might One Day Help Lower Cholesterol http://www.drugs.com/news/shot-might-one-day-help-lower-cholesterol-34846.html Blood Thinner Xarelto Shows Promise for Heart Patients http://www.drugs.com/news/blood-thinner-xarelto-shows-promise-heart-patients-34831.html New Treatment May Boost Survival in Advanced Lung Cancer Cases http://www.drugs.com/news/new-may-boost-survival-advanced-lung-cancer-cases-34777.html More Evidence That HPV Vaccine Shields Against Cervical Cancer http://www.drugs.com/news/more-evidence-hpv-vaccine-shields-against-cervical-cancer-34761.html Vaccine to Treat Breast, Ovarian Cancers Shows Promise http://www.drugs.com/news/vaccine-breast-ovarian-cancers-shows-promise-34751.html New Drug Shows Promise Against Huntington's Disease http://www.drugs.com/news/new-shows-promise-against-huntington-s-34733.html More People Landing in the ER After Abusing Muscle Relaxant: Report http://www.drugs.com/news/more-landing-er-after-abusing-muscle-relaxant-report-34661.html Too Many Meds May Be More Problem Than Cure http://www.drugs.com/news/many-meds-may-more-problem-than-cure-34649.html New Drug Targets Underlying Cause of Cystic Fibrosis http://www.drugs.com/news/new-targets-underlying-cause-cystic-fibrosis-34642.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Recall: Virility Max - Undeclared Drug Ingredient http://www.drugs.com/fda/virility-max-recall-undeclared-ingredient-13046.html Label Change: Trilipix (fenofibric acid) - Drug Safety Communication http://www.drugs.com/fda/trilipix-fenofibric-acid-safety-communication-label-change-13044.html Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events http://www.drugs.com/fda/avandia-rosiglitazone-rems-risk-cardiovascular-events-13042.html Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults http://www.drugs.com/fda/tumor-necrosis-factor-tnf-blockers-azathioprine-mercaptopurine-update-reports-hepatosplenic-t-cell-13043.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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