Drugs.com Newsletter Vol 73 - September 2010 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- Medicines Pose Greater Threat to Kids Than Chemicals September 2010 - Most parents these days are mindful of obvious poisoning risks to their children Read more: http://www.drugs.com/news/medicines-pose-greater-threat-kids-than-chemicals-26712.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Beyaz (drospirenone, ethinyl estradiol and levomefolate calcium) Tablets http://www.drugs.com/beyaz.html Date of Approval: September 24, 2010 Treatment for: Contraception, Premenstrual Dysphoric Disorder, Acne Beyaz Drug Information: http://www.drugs.com/beyaz.html Press Release: http://www.drugs.com/newdrugs/fda-approves-beyaz-combination-contraceptive-containing-folate-2308.html Gilenya (fingolimod) Capsules http://www.drugs.com/gilenya.html Date of Approval: September 21, 2010 Treatment for: Multiple Sclerosis Gilenya Drug Information: http://www.drugs.com/gilenya.html Press Release: http://www.drugs.com/newdrugs/novartis-gains-fda-approval-gilenya-novel-first-line-multiple-sclerosis-shown-significantly-reduce-2305.html Krystexxa (pegloticase) Injection http://www.drugs.com/krystexxa.html Date of Approval: September 14, 2010 Treatment for: Gout Krystexxa Drug Information: http://www.drugs.com/krystexxa.html Press Release: http://www.drugs.com/newdrugs/fda-approves-krystexxa-pegloticase-gout-2297.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Faslodex (fulvestrant) Injection http://www.drugs.com/faslodex.html New Dosage Regimen: September 9, 2010 Now Approved: 500 mg Injection Faslodex Drug Information: http://www.drugs.com/faslodex.html Press Release: http://www.drugs.com/newdrugs/fda-approves-new-dosing-faslodex-fulvestrant-metastatic-breast-cancer-hr-postmenopausal-women-2292.html Ozurdex (dexamethasone) Intravitreal Implant http://www.drugs.com/ozurdex.html New Indication Approved: September 24, 2010 Now Approved for: Non-Infectious Uveitis Ozurdex Drug Information: http://www.drugs.com/ozurdex.html Press Release: http://www.drugs.com/newdrugs/allergan-receives-fda-approval-ozurdex-option-non-infectious-uveitis-affecting-posterior-segment-eye-2307.html Protopam Chloride (pralidoxime chloride) Injection http://www.drugs.com/mtm/protopam-chloride.html Patient Population Altered: September 8, 2010 Now Approved for: Pediatric Patients Protopam Chloride Drug Information: http://www.drugs.com/mtm/protopam-chloride.html Press Release: http://www.drugs.com/newdrugs/fda-approves-pediatric-protopam-chloride-chemical-poisoning-2294.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.Norethindrone and Ethinyl Estradiol Tablets (Chewable), and Ferrous Fumarate Tablets, (Chewable) 0.4 mg/0.035 mg/75 mg (28-Day Regimen) Approved: August 5, 2010 - Barr Laboratories, Inc. Generic for: Femcon FeTrospium Chloride Tablets 20 mg Approved: August 13, 2010 - Glenmark Generics Ltd. Generic for: SancturaAtomoxetine Hydrochloride Capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg Approved: August 30, 2010 - Actavis Elizabeth LLC; Sun Pharma Global; Mylan Pharmaceuticals, Inc. Generic for: Strattera Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- How Much Is A Life Worth? $93,000 Cancer Drug Pushes Boundaries, And Patients Feel The Pinch http://www.drugs.com/news/much-worth-93-000-cancer-pushes-boundaries-patients-feel-pinch-26867.html As Science Unlocks Secrets, Cancer Rates Fall http://www.drugs.com/news/science-unlocks-secrets-cancer-rates-fall-26834.html Over 3,400 sites join DEA Nationwide Effort to Take-Back Prescription Drugs On Sept 25 http://www.drugs.com/news/over-3-400-join-dea-nationwide-effort-back-sept-25-26697.html Use of Marijuana, Ecstasy, Methamphetamine on Rise in U.S. http://www.drugs.com/news/marijuana-ecstasy-methamphetamine-rise-u-s-26689.html Childhood Vaccination Rates Remain High in U.S. http://www.drugs.com/news/childhood-vaccination-rates-remain-u-s-26684.html Helping Smokers Quit Could Save U.S. Money: Report http://www.drugs.com/news/helping-smokers-quit-could-save-u-s-money-report-26653.html Expert Panel Links Popular Bone Drugs to Rare Fracture http://www.drugs.com/news/expert-panel-links-popular-bone-rare-fracture-26624.html Smokeless Tobacco Products Can Be Deadly http://www.drugs.com/news/smokeless-tobacco-products-can-deadly-26612.html More Evidence That Vaccines Don't Cause Autism http://www.drugs.com/news/more-evidence-vaccines-don-t-cause-autism-26607.html Substance Abuse Admissions Double Among Older Adults http://www.drugs.com/news/substance-abuse-admissions-double-among-older-adults-26554.html Proximity Affects Influence of Online 'Health Buddies' http://www.drugs.com/news/proximity-affects-influence-online-health-buddies-26440.html Prescription Drug Use Rising in U.S., CDC Reports http://www.drugs.com/news/rising-u-s-cdc-reports-26432.html Study Identifies Risks for Painkiller Addiction http://www.drugs.com/news/study-identifies-risks-painkiller-26431.html Diabetes Drug Metformin Linked to Lower Lung Cancer Rate in Mice http://www.drugs.com/news/diabetes-metformin-linked-lower-lung-cancer-rate-mice-26414.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Recall: Epogen and Procrit (epoetin alfa) - Particulate Matter in Vials http://www.drugs.com/fda/epogen-procrit-epoetin-alfa-recall-particulate-matter-vials-12810.html Market Withdrawal: Octagam (Immune Globulin Intravenous (human)) - Risk of Thromboembolic Events http://www.drugs.com/fda/octagam-immune-globulin-intravenous-human-5-37-liquid-preparation-market-risk-thromboembolic-events-12809.html Recall: Similac Powder Infant Formulas http://www.drugs.com/fda/similac-powder-infant-formulas-recall-12807.html Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events http://www.drugs.com/fda/avandia-rosiglitazone-rems-risk-cardiovascular-events-12805.html Recall: Aromatase Inhibitors in Products Marketed as Dietary Supplements http://www.drugs.com/fda/aromatase-inhibitors-products-marketed-dietary-supplements-recall-12803.html Ongoing Safety Review: Actos (pioglitazone) - Potential Increased Risk of Bladder Cancer http://www.drugs.com/fda/actos-pioglitazone-ongoing-safety-review-potential-increased-risk-bladder-cancer-12804.html Labeling Change for Valcyte - Possible Overdose in Pediatric Patients http://www.drugs.com/fda/valcyte-valganciclovir-hydrochloride-label-change-possible-overdose-pediatric-patients-12802.html Labeling Change for Gadolinium-based Contrast Agents - Risk of Nephrogenic Systemic Fibrosis http://www.drugs.com/fda/gadolinium-based-contrast-agents-class-labeling-change-risk-nephrogenic-systemic-fibrosis-12799.html Labeling Change for Tygacil (tigecycline) - Increased Mortality Risk http://www.drugs.com/fda/tygacil-tigecycline-label-change-increased-mortality-risk-12797.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 - 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