Drugs.com Newsletter Vol 85 - September 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 - September 2011 September 2011 - JAMA Study: Atypical Antipsychotics Have Variable Efficacy, Safety Risk in Off-Label Uses First, as an important reminder, the atypical antipsychotic class already has a black box warning for increased mortality risk in off-label use in dementia-related psychosis Read more: http://www.drugs.com/news/monthly-roundup-september-2011-33977.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Prolia (denosumab) Injection http://www.drugs.com/prolia.html New Indication Approved: September 16, 2011 Now Approved for: Cancer Treatment-Induced Bone Loss Prolia Drug Information: http://www.drugs.com/prolia.html Press Release: http://www.drugs.com/newdrugs/fda-approves-new-indications-prolia-denosumab-bone-loss-patients-prostate-breast-cancer-undergoing-2868.html Soliris (eculizumab) Injection http://www.drugs.com/soliris.html New Indication Approved: September 23, 2011 Now Approved for: Atypical Hemolytic Uremic Syndrome Soliris Drug Information: http://www.drugs.com/soliris.html Press Release: http://www.drugs.com/newdrugs/soliris-eculizumab-approved-fda-all-patients-atypical-hemolytic-uremic-syndrome-ahus-2872.html Remicade (infliximab) Injection http://www.drugs.com/remicade.html Patient Population Altered: September 26, 2011 Now Approved for: Ulcerative Colitis in Children Older than 6 Years Remicade Drug Information: http://www.drugs.com/remicade.html Press Release: http://www.drugs.com/newdrugs/fda-approves-remicade-ulcerative-colitis-children-older-than-6-years-2874.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. Tranexamic Acid Injection 100 mg/mL; packaged in 1000 mg/10 mL single-dose vials Approved: August 10, 2011 - Pharmaforce Inc. Generic for: Cyklokapron Injection Gatifloxacin Ophthalmic Solution 0.3% Approved: August 19, 2011 - Apotex Corp. Generic for: Zymar Ophthalmic Solution Ketoconazole Foam 2% Approved: August 25, 2011 - Perrigo Israel Pharmaceuticals Ltd. Generic for: Extina Foam, 2% Cevimeline Hydrochloride Capsules 30 mg Approved: August 25, 2011 - Apotex Inc. Generic for: Evoxac Capsules, 30 mg Prilocaine Hydrochloride with Epinephrine Injection USP, 4%/1:200,000; packaged in cartridges for dental use Approved: August 30, 2011 - Septodont Inc. Generic for: Citanest Forte Dental Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Number of U.S. Kids on ADHD Meds Keeps Rising http://www.drugs.com/news/number-u-s-kids-adhd-meds-keeps-rising-33930.html Mixed Results Seen With 'Off-Label' Use of Antipsychotics http://www.drugs.com/news/mixed-results-seen-off-label-antipsychotics-33919.html Certain Antidepressants With Blood Thinners May Pose Risk for Heart Patients http://www.drugs.com/news/certain-antidepressants-blood-thinners-may-pose-risk-heart-patients-33892.html CDC Considers Vaccinating Boys, Not Just Girls, for HPV http://www.drugs.com/news/cdc-considers-vaccinating-boys-not-just-girls-hpv-33845.html FDA: Over-the-counter Asthma Inhalers Containing chloroflouorocarbons (CFCs) Will no Longer be Made or Sold After Dec. 31, 2011 http://www.drugs.com/news/fda-over-counter-asthma-inhalers-containing-chloroflouorocarbons-cfcs-no-longer-made-sold-after-dec-33844.html Popular Diabetes Drugs May Raise Pancreatic Cancer Risk, Study Suggests http://www.drugs.com/news/popular-diabetes-may-raise-pancreatic-cancer-risk-study-suggests-33833.html CDC Urges Americans: Get Your Flu Shot http://www.drugs.com/news/cdc-urges-americans-your-flu-shot-33804.html The War on Cancer Continues http://www.drugs.com/news/war-cancer-continues-33775.html Vaccinations Aren't Just for Kids http://www.drugs.com/news/vaccinations-aren-t-just-kids-33722.html Accidental Medication Poisonings in Kids on the Rise http://www.drugs.com/news/accidental-poisonings-kids-rise-33712.html Fear of Antidepressants Keep Many From Disclosing Depression http://www.drugs.com/news/fear-antidepressants-keep-many-disclosing-depression-33629.html Public Often Unaware of a Drug's Safety Record -- Or Lack of One http://www.drugs.com/news/public-often-unaware-s-safety-record-lack-one-33619.html Insulin Spray May Improve Alzheimer's Symptoms http://www.drugs.com/news/insulin-may-improve-alzheimer-s-33616.html Over Half of Adverse Drug Reactions in Hospitals Are Preventable: Study http://www.drugs.com/news/over-adverse-reactions-hospitals-preventable-study-33597.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-13028.html Recall: Qualitest Pharmaceuticals Oral Contraceptives - Packaging Error http://www.drugs.com/fda/qualitest-pharmaceuticals-oral-contraceptives-recall-packaging-error-13026.html Recall: H & P Industries Povidone Iodine Prep Pads - Potential Microbial Contamination http://www.drugs.com/fda/h-p-industries-povidone-iodine-prep-pads-recall-potential-microbial-contamination-13027.html Drug Safety Communication: Zofran (ondansetron) - Risk of Abnormal Heart Rhythms http://www.drugs.com/fda/zofran-ondansetron-safety-communication-risk-abnormal-heart-rhythms-13025.html Label Change: Tumor Necrosis Factor-alpha (TNFα) Blocker - Boxed Warning Updated for Risk of Infection from Legionella and Listeria http://www.drugs.com/fda/tumor-necrosis-factor-alpha-tnf-alpha-blockers-label-change-boxed-warning-updated-risk-infection-13023.html Drug Safety Communication: Reclast (zoledronic acid) - New Contraindication and Updated Warning on Kidney Impairment http://www.drugs.com/fda/reclast-zoledronic-acid-safety-communication-new-updated-warning-kidney-impairment-13020.html Drug Safety Communication: Saphris (asenapine maleate) - Serious Allergic Reactions http://www.drugs.com/fda/saphris-asenapine-maleate-safety-communication-serious-allergic-reactions-13022.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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