Drugs.com Newsletter Vol 88 - December 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 - December 2011 December 2011 - Durasal and Durezol: Potential for Patient Injury Due to Name Mix-Up The Food and Drug Administration (FDA) is alerting pharmacists and other health care providers of the potential for ocular injury if the unapproved prescription drug Durasal (salicylic acid) is confused with the FDA-approved medication Durezol (difluprednate ophthalmic emulsion) Read more: http://www.drugs.com/news/monthly-roundup-december-2011-35662.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Edarbyclor (azilsartan medoxomil and chlorthalidone) Tablets http://www.drugs.com/edarbyclor.html Date of Approval: December 20, 2011 Treatment for: Hypertension Edarbyclor Drug Information: http://www.drugs.com/edarbyclor.html Press Release: http://www.drugs.com/newdrugs/fda-approves-edarbyclor-azilsartan-medoxomil-chlorthalidone-hypertension-3005.html Anturol (oxybutynin) Gel http://www.drugs.com/anturol.html Date of Approval: December 7, 2011 Treatment for: Overactive Bladder Anturol Drug Information: http://www.drugs.com/anturol.html Press Release: http://www.drugs.com/newdrugs/anturol-approved-fda-overactive-bladder-2995.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Opana (oxymorphone) Tablets and ER Tablets http://www.drugs.com/opana.html New Formulation Approved: December 9, 2011 Now Approved: Opana ER Crush-Resistant Formulation Opana Drug Information: http://www.drugs.com/opana.html Press Release: http://www.drugs.com/newdrugs/endo-announces-fda-approval-new-formulation-opana-er-designed-crush-resistant-2997.html Isentress (raltegravir) Tablets http://www.drugs.com/isentress.html Patient Population Altered: December 21, 2011 Now Approved for: HIV Infection in Children and Adolescents Isentress Drug Information: http://www.drugs.com/isentress.html Press Release: http://www.drugs.com/newdrugs/fda-expands-hiv-isentress-children-adolescents-3006.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.Tiagabine Hydrochloride Tablets 2 mg and 4 mg Approved: November 4, 2011 - Sun Pharmaceutical Industries, Ltd. Generic for: GabitrilLevocetirizine Dihydrochloride Oral Solution 2.5 mg/5 mL Approved: November 7, 2011 - Synthon Pharmaceuticals, Inc. Generic for: Xyzal Oral SolutionMorphine Sulfate Extended-Release Capsules USP 20 mg, 30 mg, 50 mg, 60 mg, 80 mg and 100 mg Approved: November 10, 2011 - Watson Laboratories, Inc. Generic for: KadianEprosartan Mesylate Tablets 400 mg (base) and 600 mg (base) Approved: November 16, 2011 - Mylan Pharmaceuticals, Inc. Generic for: TevetenImipenem and Cilastatin for Injection USP, (I.V.) 250 mg/250 mg (base) and 500 mg/500 mg (base) Approved: November 16, 2011 - Hospira Inc. Generic for: Primaxin I.V.Lamivudine Tablets 150 mg and 300 mg Approved: November 17, 2011 - Aurobindo Pharma USA, Inc. Generic for: Epivir TabletsSodium Phenylbutyrate Tablets 500 mg Approved: November 18, 2011 - Amplogen Pharmaceuticals, LLC Generic for: Buphenyl TabletsAtorvastatin Calcium Tablets 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base) Approved: November 30, 2011 - Ranbaxy Laboratories Limited Generic for: Lipitor Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Health Care Reform Battle Tops Health News for 2011 http://www.drugs.com/news/health-care-reform-battle-tops-health-news-2011-35628.html Cases of Tamiflu-Resistant Flu Concern Experts http://www.drugs.com/news/cases-tamiflu-resistant-flu-concern-experts-35616.html FDA Alerts Pharmacists and Health Care Professionals to Potential for Injury when Dispensing the Similar-Sounding Drugs Durezol and Durasal http://www.drugs.com/news/fda-alerts-pharmacists-health-care-professionals-potential-injury-dispensing-similar-sounding-35659.html How to Make Your Quit-Smoking Resolution Stick http://www.drugs.com/news/make-your-quit-smoking-resolution-stick-35574.html Limit Cold Medications During Pregnancy, Experts Advise http://www.drugs.com/news/limit-cold-during-pregnancy-experts-advise-35521.html Treating High Blood Pressure May Add Years to Life http://www.drugs.com/news/treating-blood-pressure-may-add-years-35496.html Drug Overdoses Kill More Americans Than Car Accidents: CDC http://www.drugs.com/news/overdoses-kill-more-americans-than-car-accidents-cdc-35489.html Poor Lifestyles Harming U.S. Heart Health: Report http://www.drugs.com/news/poor-lifestyles-harming-u-s-heart-health-report-35412.html Many Toddlers Wind Up in ER After Accidental Overdose http://www.drugs.com/news/many-toddlers-wind-up-er-after-accidental-overdose-35345.html Side Effects Cause Many Older Women to Drop Breast Cancer Drugs http://www.drugs.com/news/cause-many-older-women-drop-breast-cancer-35328.html ADHD Drugs Don't Raise Risk of Heart Problems: Study http://www.drugs.com/news/adhd-don-t-raise-risk-heart-problems-study-35327.html CDC Issues New TB Treatment Guidelines http://www.drugs.com/news/cdc-issues-new-tb-guidelines-35284.html Expert Panel Pinpoints Environmental Culprits in Breast Cancer http://www.drugs.com/news/expert-panel-pinpoints-environmental-culprits-breast-cancer-35251.html FDA Targets Homeopathic Weight Loss Products http://www.drugs.com/news/fda-targets-homeopathic-weight-loss-products-35222.html Targeted Drugs, Lung CT Screening Top Cancer Advances in 2011 http://www.drugs.com/news/targeted-lung-ct-screening-top-cancer-advances-2011-35208.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors http://www.drugs.com/fda/liquid-acetaminophen-marketed-infants-safety-communication-potential-dosing-errors-13059.html Recall: Eclectic Institute Dietary Supplements - Possible Salmonella Contamination http://www.drugs.com/fda/eclectic-institute-dietary-supplements-recall-possible-salmonella-contamination-13060.html Drug Safety Communication: Gilenya (fingolimod) - Safety Review of a Reported Death After the First Dose http://www.drugs.com/fda/gilenya-fingolimod-safety-communication-safety-review-reported-death-after-first-13056.html Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events http://www.drugs.com/fda/multaq-dronedarone-safety-communication-increased-risk-death-serious-cardiovascular-events-13055.html Zocor (simvastatin) Label Change Update: New Restrictions, Contraindications, and Dose Limitations http://www.drugs.com/fda/zocor-simvastatin-label-change-new-restrictions-contraindications-limitations-13054.html Drug Safety Communication: Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn http://www.drugs.com/fda/selective-serotonin-reuptake-inhibitor-ssri-antidepressants-safety-communication-during-pregnancy-13053.html Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) - Safety Review of Post-Market Reports of Serious Bleeding Events http://www.drugs.com/fda/pradaxa-dabigatran-etexilate-mesylate-safety-communication-safety-review-post-market-reports-13048.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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