Drugs.com Newsletter Vol 60 - August 2009 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- U.S. Childhood Vaccine Rates Good But Could Be Better: CDC August 2009 - More than three-quarters of United States children have received the recommended vaccinations, but greater efforts are needed to reach youngsters who are not fully immunized, a US government report finds Read more: http://www.drugs.com/news/u-s-childhood-vaccine-rates-good-but-could-be-better-cdc-19568.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Zenpep (pancrealipase) Capsules http://www.drugs.com/zenpep.html Date of Approval: August 27, 2009 Treatment for: Pancreatic Exocrine Dysfunction Zenpep Drug Information: http://www.drugs.com/zenpep.html Press Release: http://www.drugs.com/newdrugs/eurand-granted-fda-approval-for-zenpep-1572.html Sabril (vigabatrin) Tablets and Oral Solution http://www.drugs.com/sabril.html Date of Approval: August 21, 2009 Treatment for: Epilepsy, Seizures Sabril Drug Information: http://www.drugs.com/sabril.html Press Release: http://www.drugs.com/newdrugs/lundbeck-inc-announces-fda-marketing-approval-for-sabril-for-the-treatment-of-two-difficult-to-treat-epilepsies-1567.html Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) Solution for Intramuscular Injection http://www.drugs.com/hiberix.html Date of Approval: August 19, 2009 Treatment for: Haemophilus influenzae Prophylaxis Hiberix Drug Information: http://www.drugs.com/hiberix.html Press Release: http://www.drugs.com/newdrugs/fda-approves-gsk-s-hib-vaccine-hiberix-1564.html Saphris (asenapine) Sublingual Tablets http://www.drugs.com/saphris.html Date of Approval: August 13, 2009 Treatment for: Schizophrenia, Bipolar Disorder Saphris Drug Information: http://www.drugs.com/saphris.html Press Release: http://www.drugs.com/newdrugs/schering-plough-announces-fda-approval-of-saphris-asenapine-1558.html Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules http://www.drugs.com/embeda.html Date of Approval: August 13, 2009 Treatment for: Pain Embeda Drug Information: http://www.drugs.com/embeda.html Press Release: http://www.drugs.com/newdrugs/fda-approves-embeda-for-management-of-moderate-to-severe-chronic-pain-1557.html Livalo (pitavastatin) Tablets http://www.drugs.com/livalo.html Date of Approval: August 3, 2009 Treatment for: High Cholesterol Livalo Drug Information: http://www.drugs.com/livalo.html Press Release: http://www.drugs.com/newdrugs/fda-approves-livalo-for-primary-hypercholesterolemia-and-combined-dyslipidemia-1545.html Lipsovir (acyclovir and hydrocortisone) Topical Cream http://www.drugs.com/lipsovir.html Date of Approval: July 31, 2009 Treatment for: Herpes Simplex Labialis Lipsovir Drug Information: http://www.drugs.com/lipsovir.html Press Release: http://www.drugs.com/newdrugs/the-us-fda-approves-lipsovir-for-marketing-and-sales-in-us-1544.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Invega (paliperidone) http://www.drugs.com/invega.html New Dosage Form Approved: July 31, 2009 Now Approved: Invega Sustenna Invega Drug Information: http://www.drugs.com/invega.html Press Release: http://www.drugs.com/newdrugs/fda-approves-invega-sustenna-for-the-acute-and-maintenance-treatment-of-schizophrenia-1543.html Invega (paliperidone) http://www.drugs.com/invega.html New Indication Approved: July 31, 2009 Now Approved for: Schizoaffective Disorder Invega Drug Information: http://www.drugs.com/invega.html Press Release: http://www.drugs.com/newdrugs/invega-approved-as-the-first-and-only-treatment-for-schizoaffective-disorder-1550.html Avastin (bevacizumab) Injection http://www.drugs.com/avastin.html New Indication Approved: July 31, 2009 Now Approved for: Metastatic Renal Cell Carcinoma Avastin Drug Information: http://www.drugs.com/avastin.html Press Release: http://www.drugs.com/newdrugs/fda-approves-avastin-for-the-most-common-type-of-kidney-cancer-1521.html Xyzal (levocetirizine dihydrochloride) http://www.drugs.com/xyzal.html Patient Population Altered: August 21, 2009 Now Approved for: Allergy Symptoms in Children Six Months and Older Xyzal Drug Information: http://www.drugs.com/xyzal.html Press Release: http://www.drugs.com/newdrugs/fda-approves-xyzal-for-use-in-children-age-six-months-and-older-for-the-relief-of-perennial-allergic-rhinitis-and-chronic-idiopathic-urticaria-1568.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. Bicalutamide Tablets 50 mg Approved: July 6, 2009 Teva Pharmaceuticals; Synthon Pharmaceuticals, Inc.; Kudco; Sandoz; Accord Healthcare Inc.; Zydus Pharmaceuticals; Sun Pharmaceutical Industries Ltd; Mylan Pharmaceuticals Generic for: Casodex Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Americans Are Urged to Cut Sugar Intake http://www.drugs.com/news/americans-are-urged-to-cut-sugar-intake-19494.html Not Everyone Wants to Be Vaccinated Against Pandemic Flu http://www.drugs.com/news/not-everyone-wants-to-be-vaccinated-against-pandemic-flu-19481.html Abuse of ADHD Drugs on the Rise http://www.drugs.com/news/abuse-of-adhd-drugs-on-the-rise-19482.html Off-label use: Oft not evidence based http://www.drugs.com/news/off-label-use-oft-not-evidence-based-19458.html School Kids, Parents Should Get Flu Vaccines First http://www.drugs.com/news/school-kids-parents-should-get-flu-vaccines-first-19444.html Patch 'Shots' May Someday Replace Injections http://www.drugs.com/news/patch-shots-may-someday-replace-injections-19416.html Antibiotics Being Prescribed Less for Respiratory Infections http://www.drugs.com/news/antibiotics-being-prescribed-less-for-respiratory-infections-19400.html 'Cruise Ship Virus' Vaccine Stems From Tobacco http://www.drugs.com/news/cruise-ship-virus-vaccine-stems-from-tobacco-19388.html Antioxidants Pose No Melanoma Threat http://www.drugs.com/news/antioxidants-pose-no-melanoma-threat-19375.html Chewing Tobacco No Safer Than Smoking http://www.drugs.com/news/chewing-tobacco-no-safer-than-smoking-19369.html Survey Finds Binge Drinking Among Older People, Too http://www.drugs.com/news/survey-finds-binge-drinking-among-older-people-too-19365.html Web Is Becoming One-Stop Shopping for Health Help http://www.drugs.com/news/web-is-becoming-one-stop-shopping-for-health-help-19360.html International Travel Health Guidebook Gets Updated http://www.drugs.com/news/international-travel-health-guidebook-gets-updated-19359.html They Snooze Less, But They Don't Lose http://www.drugs.com/news/they-snooze-less-but-they-don-t-lose-19332.html FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs http://www.drugs.com/news/fda-issues-final-rules-to-help-patients-gain-access-to-investigational-drugs-19317.html Folk Medicine Therapy May Prevent Alcoholic Relapse http://www.drugs.com/news/folk-medicine-therapy-may-prevent-alcoholic-relapse-19300.html Suicide Risk With Antidepressants Falls With Age http://www.drugs.com/news/suicide-risk-with-antidepressants-falls-with-age-19295.html Sharing Prescription Meds Common Among U.S. Teens http://www.drugs.com/news/sharing-prescription-meds-common-among-u-s-teens-19261.html In U.S., No Comeback Seen for Hormone Therapy http://www.drugs.com/news/in-u-s-no-comeback-seen-for-hormone-therapy-19254.html When Kids Are Hospitalized, Parents Fret About Errors http://www.drugs.com/news/when-kids-are-hospitalized-parents-fret-about-errors-19244.html Many Texas Docs Not Pushing HPV Vaccine for Girls http://www.drugs.com/news/many-texas-docs-not-pushing-hpv-vaccine-for-girls-19223.html U.S. Spending on Mental Health Care Soaring http://www.drugs.com/news/u-s-spending-on-mental-health-care-soaring-19201.html Medicines Top Source of Kids' Poisonings http://www.drugs.com/news/medicines-top-source-of-kids-poisonings-19156.html Antidepressant Use in U.S. Has Almost Doubled http://www.drugs.com/news/antidepressant-use-in-u-s-has-almost-doubled-19147.html One in 10 High School Seniors Have Used Narcotic Painkillers http://www.drugs.com/news/one-in-10-high-school-seniors-have-used-narcotic-painkillers-19148.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Update: FDA Warns Tumor Necrosis Factor (TNF) Blockers May Increase Cancer Risk http://www.drugs.com/fda/tumor-necrosis-factor-tnf-blockers-marketed-as-remicade-enbrel-humira-cimzia-and-simponi-august-2009-12589.html Update on Leukotriene Inhibitors: Precaution Labeling for Possible Neuropsychiatric Events http://www.drugs.com/fda/leukotriene-inhibitors-montelukast-marketed-as-singulair-zafirlukast-marketed-as-accolate-and-zileuton-marketed-as-zyflo-and-zyflo-cr-12588.html Tibotec and FDA Update Warnings for Intelence http://www.drugs.com/fda/intelence-etravirine-12587.html FDA Warns Stolen Levemir Insulin May Still Be On Market http://www.drugs.com/fda/levemir-insulin-novo-nordisk-12586.html Voluntary Nationwide Recall of Accusure Insulin Syringes [31G, 1/2 cc and 1 cc] http://www.drugs.com/fda/accusure-insulin-syringes-31g-1-2-cc-and-1-cc-12585.html FDA Reviewing Reports of Liver Failure with Weight Loss Drug Orlistat (marketed as Alli and Xenical) http://www.drugs.com/fda/orlistat-marketed-as-alli-and-xenical-early-communication-about-an-ongoing-safety-review-12584.html Expanded Recall of Steam Dietary Supplement http://www.drugs.com/fda/steam-dietary-supplement-12583.html FDA Issues Warnings on Unapproved Topical Ibuprofen http://www.drugs.com/fda/ibuprofen-unapproved-topical-drug-products-12581.html FDA Warns of Pure Red Cell Aplasia (PRCA) in CellCept Patients http://www.drugs.com/fda/cellcept-mycophenolate-mofetil-august-2009-12579.html Voluntary Recall of Dextroamphetamine/Amphetamine 20mg Tablets - Barr Laboratories, Inc. http://www.drugs.com/fda/dextroamphetamine-amphetamine-20mg-tablets-12578.html FDA Warns of Potentially Fatal Errors with GDH-PQQ Glucose Monitoring Technology http://www.drugs.com/fda/gdh-pqq-glucose-dehydrogenase-pyrroloquinoline-quinone-glucose-monitoring-technology-12577.html FDA Warns Tumor Necrosis Factor (TNF) Blockers May Increase Cancer Risk http://www.drugs.com/fda/tumor-necrosis-factor-tnf-blockers-marketed-as-remicade-enbrel-humira-cimzia-and-simponi-12574.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_index.html 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 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