Drugs.com Newsletter Vol 83 - July 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 - July 2011 July 2011 - We know it's still summer, but don't forget: those flu shots are due to be renewed each fall Read more: http://www.drugs.com/news/monthly-roundup-july-2011-32794.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Brilinta (ticagrelor) Tablets http://www.drugs.com/brilinta.html Date of Approval: July 20, 2011 Treatment for: Acute Coronary Syndrome Brilinta Drug Information: http://www.drugs.com/brilinta.html Press Release: http://www.drugs.com/newdrugs/fda-approves-blood-thinning-brilinta-acute-coronary-syndromes-2784.html Xarelto (rivaroxaban) Tablets http://www.drugs.com/xarelto.html Date of Approval: July 1, 2011 Treatment for: Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery Xarelto Drug Information: http://www.drugs.com/xarelto.html Press Release: http://www.drugs.com/newdrugs/fda-approves-xarelto-rivaroxaban-prevent-deep-vein-thrombosis-patients-undergoing-knee-hip-2747.html Arcapta (indacaterol) Neohaler http://www.drugs.com/arcapta.html Date of Approval: July 1, 2011 Treatment for: Chronic Obstructive Pulmonary Disease Arcapta Drug Information: http://www.drugs.com/arcapta.html Press Release: http://www.drugs.com/newdrugs/fda-approves-arcapta-neohaler-chronic-obstructive-pulmonary-2746.html Lazanda (fentanyl) Nasal Spray http://www.drugs.com/lazanda.html Date of Approval: June 30, 2011 Treatment for: Pain Lazanda Drug Information: http://www.drugs.com/lazanda.html Press Release: http://www.drugs.com/newdrugs/fda-approves-lazanda-first-fentanyl-nasal-management-breakthrough-pain-cancer-patients-2740.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Lialda (mesalamine) Delayed Release Tablets http://www.drugs.com/lialda.html Labeling Revision Approved: July 14, 2011 Now Approved for: Maintenance of Remission of Ulcerative Colitis Lialda Drug Information: http://www.drugs.com/lialda.html Press Release: http://www.drugs.com/newdrugs/lialda-mesalamine-now-approved-u-s-maintenance-remission-ulcerative-colitis-2782.html Welchol (colesevelam) Tablets and Oral Suspension http://www.drugs.com/mtm/welchol.html Labeling Revision Approved: July 18, 2011 Now Approved: Mixing Oral Suspension With Fruit Juice or Diet Soft Drinks Welchol Drug Information: http://www.drugs.com/mtm/welchol.html Press Release: http://www.drugs.com/newdrugs/once-daily-welchol-colesevelam-hcl-oral-suspension-receives-fda-approval-mixed-fruit-juice-diet-2794.html Gammagard Liquid (immune globulin infusion (human)) Solution http://www.drugs.com/gammagard.html New Dosage Form Approved: July 25, 2011 Now Approved: Subcutaneous Route of Administration Gammagard Liquid Drug Information: http://www.drugs.com/gammagard.html Press Release: http://www.drugs.com/newdrugs/baxter-announces-fda-approval-subcutaneous-route-administration-gammagard-liquid-patients-primary-2792.html Xeomin (incobotulinumtoxinA) http://www.drugs.com/xeomin.html New Indication Approved: July 21, 2011 Now Approved for: Glabellar Lines Xeomin Drug Information: http://www.drugs.com/xeomin.html Press Release: http://www.drugs.com/newdrugs/merz-aesthetics-announces-fda-approval-xeomin-incobotulinumtoxina-temporary-improvement-appearance-2786.html Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)) http://www.drugs.com/boostrix.html Patient Population Altered: July 8, 2011 Now Approved for: Seniors 65 and over Boostrix Drug Information: http://www.drugs.com/boostrix.html Press Release: http://www.drugs.com/newdrugs/fda-approves-boostrix-prevent-tetanus-diphtheria-pertussis-older-2753.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.Ethinyl Estradiol and Levonorgestrel Tablets USP 0.02 mg/0.09 mg Approved: June 6, 2011 - Watson Laboratories, Inc. Generic for: LybrelClobetasol Propionate Shampoo 0.05% Approved: June 7, 2011 - Actavis Mid Atlantic, LLC Generic for: Clobex ShampooClobetasol Propionate Topical Solution USP, (Spray) 0.05% Approved: June 16, 2011 - Paddock Laboratories, Inc. Generic for: Clobex SprayLevofloxacin Injection 25 mg/mL; packaged in 500 mg/20 mL and 750 mg/30 mL Single-Use Vials Approved: June 20, 2011 - Akorn, Inc.; Sagent Strides, LLC Generic for: Levaquin InjectionLevofloxacin Tablets 250 mg, 500 mg and 750 mg Approved: June 20, 2011 - Aurobindo Pharma Limited; Sandoz, Inc.; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA; Dr. Reddy's Laboratories Limited; Torrent Pharmaceuticals; Wockhardt Limited; Glenmark Generics Ltd. Generic for: Levaquin TabletsLevofloxacin Oral Solution 25 mg/mL Approved: June 20, 2011 - Hi-Tech Pharmacal Co., Inc. Generic for: Levaquin Oral SolutionSumatriptan Succinate Injection 6 mg (base)/0.5 mL; packaged in a Single-Dose Syringe With Autoinjector Approved: June 21, 2011 - Sun Pharma Global FZE Generic for: Imitrex Statdose SystemFexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets USP, (OTC) 180 mg/240 mg (24-Hour Formulation) Approved: June 22, 2011 - Dr. Reddy's Laboratories Limited Generic for: Allegra-D 24 Hour Extended-Release TabletsFlucytosine Capsules USP, 250 mg and 500 mg Approved: June 28, 2011 - Sigmapharm Laboratories, LLC Generic for: Ancobon Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- McNeil Consumer Healthcare Announces Plans for New Dosing Instructions for Tylenol Products http://www.drugs.com/news/mcneil-consumer-healthcare-announces-plans-new-dosing-instructions-tylenol-products-32782.html Methamphetamine Abuse May Raise Parkinson's Risk http://www.drugs.com/news/methamphetamine-abuse-may-raise-parkinson-s-risk-32726.html Antibiotics Beat Cranberries at Fighting Urinary Tract Infections in Study http://www.drugs.com/news/antibiotics-beat-cranberries-fighting-urinary-tract-infections-study-32700.html CDC Issues Guidance for Coping With Lingering Heat http://www.drugs.com/news/cdc-issues-guidance-coping-lingering-heat-32696.html Chickenpox Vaccine May Wipe Out Related Deaths: Study http://www.drugs.com/news/chickenpox-vaccine-may-wipe-out-related-deaths-study-32686.html Drug Prices to Plummet in Wave of Expiring Patents http://www.drugs.com/news/prices-plummet-wave-expiring-patents-32684.html Low 'Health Literacy' Hazardous to Your Health http://www.drugs.com/news/low-health-literacy-hazardous-your-health-32659.html Are Newer MS Drugs Worth Their High Price Tag? http://www.drugs.com/news/newer-ms-worth-their-price-tag-32630.html Experimental Drug Might Help Fight Alzheimer's After All http://www.drugs.com/news/experimental-might-help-fight-alzheimer-s-after-all-32602.html Stopping Daily Aspirin Boosts Heart Attack Risk: Study http://www.drugs.com/news/stopping-daily-aspirin-boosts-heart-attack-risk-study-32595.html U.S. Panel Recommends Free Coverage of Birth Control http://www.drugs.com/news/u-s-panel-recommends-free-coverage-birth-control-32593.html Drug May Prevent Chemo-Linked Menopause in Breast Cancer Patients http://www.drugs.com/news/may-prevent-chemo-linked-menopause-breast-cancer-patients-32592.html Two Antidepressants Given to Dementia Patients Ineffective: Study http://www.drugs.com/news/two-antidepressants-given-dementia-patients-ineffective-study-32589.html Statins Don't Seem to Raise Cancer Risk http://www.drugs.com/news/statins-don-t-seem-raise-cancer-risk-32565.html FDA Unveils Flu Vaccines for 2011-12 Season http://www.drugs.com/news/fda-unveils-flu-vaccines-2011-12-season-32559.html More Evidence That Early Treatment Can Stop HIV's Spread to Partners http://www.drugs.com/news/more-evidence-early-can-stop-hiv-s-spread-partners-32556.html Injection Drug Users Most in Need of Treatment, Study Says http://www.drugs.com/news/users-most-need-study-says-32531.html Researchers Closer to Developing Universal Meningitis B Vaccine http://www.drugs.com/news/researchers-closer-developing-universal-meningitis-b-vaccine-32525.html Certain Painkillers May Raise Odds of Stroke, Heart Attack: Study http://www.drugs.com/news/certain-painkillers-may-raise-odds-stroke-heart-attack-study-32508.html Delving Into the Mystery of Placebos http://www.drugs.com/news/delving-into-mystery-placebos-32492.html For Some Prostate Cancer Patients, Combo Treatment Improves Survival http://www.drugs.com/news/some-prostate-cancer-patients-combo-improves-survival-32493.html Drugs May Prevent HIV Spread Among Heterosexuals http://www.drugs.com/news/may-prevent-hiv-spread-among-heterosexuals-32486.html Parkinson's Patients Still Prescribed Antipsychotics Despite Warning http://www.drugs.com/news/parkinson-s-patients-still-antipsychotics-despite-warning-32439.html Gonorrhea's Growing Resistance to Antibiotics Concerns CDC http://www.drugs.com/news/gonorrhea-s-growing-resistance-antibiotics-concerns-cdc-32388.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Undeclared Drug Ingredient: Slim Forte http://www.drugs.com/fda/slim-forte-slimming-capsules-slim-forte-slimming-coffee-botanical-slimming-soft-gel-public-13009.html Drug Safety Communication: 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-13006.html Drug Safety Communication: 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-13007.html Drug Safety Communication: CardioGen-82 PET Scan - Increased Radiation Exposure http://www.drugs.com/fda/cardiogen-82-pet-scan-safety-communication-increased-radiation-exposure-13008.html Label Change: Chantix (varenicline) - Risk of Certain Cardiovascular Adverse Events http://www.drugs.com/fda/chantix-varenicline-label-change-risk-certain-cardiovascular-adverse-events-13005.html Drug Safety Communication: Oral Osteoporosis Drugs (bisphosphonates) - Potential Increased Risk of Esophageal Cancer http://www.drugs.com/fda/oral-osteoporosis-bisphosphonates-safety-communication-potential-increased-risk-esophageal-cancer-13003.html Drug Safety Communication: Multaq (dronedarone) - Increased Risk of Death or Serious Cardiovascular Events http://www.drugs.com/fda/multaq-dronedarone-safety-communication-increased-risk-death-serious-cardiovascular-events-13004.html Recall: American Regent Injectable Products - Visible Particulates in Products http://www.drugs.com/fda/american-regent-injectable-products-recall-visible-particulates-products-13002.html Label Change: Tamiflu (oseltamivir phosphate) for Oral Suspension - New Concentration (6 mg/mL) http://www.drugs.com/fda/tamiflu-oseltamivir-phosphate-oral-suspension-label-change-new-concentration-6-mg-ml-12999.html Risk Evaluation and Mitigation Strategy (REMS): Nulojix (belatacept) http://www.drugs.com/fda/nulojix-belatacept-risk-evaluation-mitigation-strategy-rems-12996.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 - 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