Drugs.com Newsletter Vol 79 - March 2011 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- Conflicts of Interest Cloud Heart Treatment Guidelines: Study March 2011 - More than half of the nearly 500 writers and reviewers of recent cardiology clinical practice guidelines reported a conflict of interest due to ties with drug makers and other companies, a new study finds Read more: http://www.drugs.com/news/conflicts-interest-cloud-heart-guidelines-study-30399.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Yervoy (ipilimumab) Injection http://www.drugs.com/yervoy.html Date of Approval: March 25, 2011 Treatment for: Melanoma - Metastatic Yervoy Drug Information: http://www.drugs.com/yervoy.html Press Release: http://www.drugs.com/newdrugs/fda-approves-yervoy-late-stage-melanoma-2569.html Gadavist (gadobutrol) Injection http://www.drugs.com/gadavist.html Date of Approval: March 14, 2011 Treatment for: Diagnostic Gadavist Drug Information: http://www.drugs.com/gadavist.html Press Release: http://www.drugs.com/newdrugs/u-s-fda-approves-bayer-s-gadavist-gadobutrol-mri-central-nervous-2560.html Benlysta (belimumab) Injection http://www.drugs.com/benlysta.html Date of Approval: March 10, 2011 Treatment for: Systemic Lupus Erythematosus Benlysta Drug Information: http://www.drugs.com/benlysta.html Press Release: http://www.drugs.com/newdrugs/fda-approves-benlysta-lupus-2552.html Daliresp (roflumilast) Tablets http://www.drugs.com/daliresp.html Date of Approval: February 28, 2011 Treatment for: Chronic Obstructive Pulmonary Disease Daliresp Drug Information: http://www.drugs.com/daliresp.html Press Release: http://www.drugs.com/newdrugs/fda-approves-daliresp-chronic-obstructive-pulmonary-2545.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Banzel (rufinamide) http://www.drugs.com/banzel.html New Dosage Form Approved: March 3, 2011 Now Approved: Banzel Oral Suspension Banzel Drug Information: http://www.drugs.com/banzel.html Press Release: http://www.drugs.com/newdrugs/fda-approves-banzel-rufinamide-oral-suspension-40-mg-ml-2548.html Viramune (nevirapine) http://www.drugs.com/mtm/viramune.html New Formulation Approved: March 25, 2011 Now Approved: Viramune XR Viramune Drug Information: http://www.drugs.com/mtm/viramune.html Press Release: http://www.drugs.com/newdrugs/fda-approves-viramune-xr-nevirapine-400-mg-extended-release-tablet-2571.html Zyclara (imiquimod) Cream http://www.drugs.com/zyclara.html New Indication Approved: March 24, 2011 Now Approved for: External Genital Warts Zyclara Drug Information: http://www.drugs.com/zyclara.html Press Release: http://www.drugs.com/newdrugs/fda-approves-zyclara-imiquimod-cream-3-75-external-genital-warts-2568.html Zostavax (zoster vaccine live) Injection http://www.drugs.com/zostavax.html Patient Population Altered: March 24, 2011 Now Approved for: Adults 50 Years of Age and Older Zostavax Drug Information: http://www.drugs.com/zostavax.html Press Release: http://www.drugs.com/newdrugs/fda-expands-indication-zostavax-merck-s-shingles-vaccine-include-adults-ages-50-59-2567.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.Gabapentin Oral Solution 250 mg/5 mL Approved: February 18, 2011 - Hi-Tech Pharmacal Co., Inc. Generic for: Neurontin Oral SolutionPioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/500 mg and 15 mg/850 mg Approved: February 25, 2011 - Mylan Pharmaceuticals, Inc. Generic for: Actoplus Met Tablets Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Parkinson's Drugs Linked to Behavior Problems in Study http://www.drugs.com/news/parkinson-s-linked-behavior-problems-study-30426.html Nicotine Raises Blood Sugar Levels in Lab http://www.drugs.com/news/nicotine-raises-blood-sugar-levels-lab-30365.html Short Course of Hormone Therapy Boosts Prostate Cancer Survival: Study http://www.drugs.com/news/short-course-hormone-therapy-boosts-prostate-cancer-survival-study-30335.html Leukemia Patients Taking Gleevec Achieve 'Normal' Death Rate http://www.drugs.com/news/leukemia-patients-gleevec-achieve-normal-death-rate-30274.html Study: Reluctance to Speak Up Encourages Medical Errors http://www.drugs.com/news/study-reluctance-speak-up-encourages-medical-errors-30273.html Tamoxifen May Offer Long-Term Heart, Cancer Protection http://www.drugs.com/news/tamoxifen-may-offer-long-term-heart-cancer-protection-30266.html Anti-Drug Message May Reach Young Girls, But Not Older Ones http://www.drugs.com/news/anti-message-may-reach-young-girls-but-not-older-ones-30213.html Parents Can Help Prevent Problem Drinking in College Kids http://www.drugs.com/news/parents-can-help-prevent-problem-drinking-college-kids-30147.html Herbal Derivative Wins Praise as Malaria Treatment http://www.drugs.com/news/herbal-derivative-wins-praise-malaria-30146.html Heavy Smoking Declines in U.S. http://www.drugs.com/news/heavy-smoking-declines-u-s-30133.html Seniors Not Getting Important Preventive Health Services http://www.drugs.com/news/seniors-not-getting-important-preventive-health-services-30126.html Metformin Still Best First-Line Type 2 Diabetes Drug http://www.drugs.com/news/metformin-still-best-first-line-type-2-diabetes-30110.html Combating Myths About Seasonal Allergies http://www.drugs.com/news/combating-myths-seasonal-allergies-30080.html Spider Research May Lead to New Therapies for Humans http://www.drugs.com/news/spider-research-may-lead-new-therapies-humans-30016.html Genes May Affect Severity of Drug Addiction http://www.drugs.com/news/genes-may-affect-severity-29990.html Diabetes Often Not Diagnosed or Treated Properly http://www.drugs.com/news/diabetes-often-not-diagnosed-treated-properly-29929.html Seniors Concerned About Side Effects of Heart Drugs http://www.drugs.com/news/seniors-concerned-heart-29858.html Blood Pressure Drugs May Help Heart Patients Without Hypertension http://www.drugs.com/news/blood-pressure-may-help-heart-patients-without-hypertension-29862.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Recall: Irinotecan Hydrochloride Injection - Fungal Microbial Contaminant http://www.drugs.com/fda/irinotecan-hydrochloride-recall-fungal-microbial-contaminant-12928.html Recall: Citalopram And Finasteride by Greenstone - Possible Mislabeling http://www.drugs.com/fda/citalopram-finasteride-greenstone-recall-possible-mislabeling-12929.html Recall: U-Prosta - Undeclared Drug Ingredient http://www.drugs.com/fda/u-prosta-undeclared-ingredient-12927.html Recall: Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks - Potential Microbial Contamination http://www.drugs.com/fda/triad-alcohol-prep-pads-alcohol-swabs-alcohol-swabsticks-recall-due-potential-microbial-12926.html Recall: H & P Industries Povidine Iodine Prep Pads - Potential Microbial Contamination http://www.drugs.com/fda/h-p-industries-povidine-iodine-prep-pads-recall-potential-microbial-contamination-12924.html Recall: American Regent Injectable Products - Visible Particulates in Products http://www.drugs.com/fda/american-regent-injectable-products-recall-visible-particulates-products-12925.html Warning: Black Ant - Undeclared Drug Ingredient http://www.drugs.com/fda/black-ant-undeclared-ingredient-12921.html Label Change: Kaletra (lopinavir/ritonavir) - Serious Health Problems in Premature Babies http://www.drugs.com/fda/kaletra-lopinavir-ritonavir-label-change-serious-health-problems-premature-babies-12919.html Label Change: Topamax (topiramate) - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns http://www.drugs.com/fda/topamax-topiramate-label-change-risk-development-cleft-lip-cleft-palate-newborns-12916.html FDA Prompts Removal From Market: Unapproved Cough, Cold, Allergy Products http://www.drugs.com/fda/unapproved-cough-cold-allergy-products-fda-prompts-removal-market-12912.html Drug Safety Communication: Proton Pump Inhibitor drugs (PPIs) - Low Magnesium Levels Can Be Associated With Long-Term Use http://www.drugs.com/fda/proton-pump-inhibitor-ppis-safety-communication-low-magnesium-levels-can-associated-long-term-12913.html Ongoing Safety Review: Abacavir - Possible Increased Risk of Heart Attack http://www.drugs.com/fda/abacavir-ongoing-safety-review-possible-increased-risk-heart-attack-12914.html More FDA Medwatch Alerts: http://www.drugs.com/fda_alerts.html TOOLS & HELPFUL LINKS --------------------- Community Discussion Forums - 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