Drugs.com Newsletter Vol 67 - March 2010 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- To Supplement or Not to Supplement? March 2010 - You know you should eat better - but that daily multivitamin pill, calcium supplements and possibly others compensate, right? Perhaps Read more: http://www.drugs.com/news/supplement-not-supplement-23467.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Zyclara (imiquimod) Cream http://www.drugs.com/zyclara.html Date of Approval: March 25, 2010 Treatment for: Actinic Keratosis Zyclara Drug Information: http://www.drugs.com/zyclara.html Press Release: http://www.drugs.com/newdrugs/fda-approves-zyclara-imiquimod-cream-3-75-actinic-keratoses-2082.html Silenor (doxepin) Tablets http://www.drugs.com/silenor.html Date of Approval: March 17, 2010 Treatment for: Insomnia Silenor Drug Information: http://www.drugs.com/silenor.html Press Release: http://www.drugs.com/newdrugs/somaxon-announces-fda-approval-silenor-doxepin-insomnia-2070.html Carbaglu (carglumic acid) Tablets http://www.drugs.com/carbaglu.html Date of Approval: March 18, 2010 Treatment for: NAGS Deficiency Hyperammonemia Carbaglu Drug Information: http://www.drugs.com/carbaglu.html Press Release: http://www.drugs.com/newdrugs/fda-approves-carbaglu-condition-causes-elevated-ammonia-levels-2071.html Hizentra (immune globulin subcutaneous (human)) Liquid http://www.drugs.com/hizentra.html Date of Approval: March 4, 2010 Treatment for: Primary Immunodeficiency Syndrome Hizentra Drug Information: http://www.drugs.com/hizentra.html Press Release: http://www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html Exalgo (hydromorphone) Extended Release Tablets http://www.drugs.com/exalgo.html Date of Approval: March 1, 2010 Treatment for: Pain in Opioid Tolerant Patients Exalgo Drug Information: http://www.drugs.com/exalgo.html Press Release: http://www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Norditropin (somatropin [rDNA origin]) Injection http://www.drugs.com/mtm/norditropin.html New Dosage Form Approved: March 1, 2010 Now Approved: Norditropin FlexPro Norditropin Drug Information: http://www.drugs.com/mtm/norditropin.html Press Release: http://www.drugs.com/newdrugs/novo-nordisk-receives-fda-approval-norditropin-flexpro-growth-hormone-2036.html Dacogen (decitabine) for Injection http://www.drugs.com/dacogen.html New Dosage Regimen: March 11, 2010 Now Approved: Five-Day Dosing Regimen Dacogen Drug Information: http://www.drugs.com/dacogen.html Press Release: http://www.drugs.com/newdrugs/fda-approves-five-day-dosing-regimen-dacogen-decitabine-offering-new-outpatient-dosing-option-2042.html Differin (adapalene) http://www.drugs.com/differin.html New Formulation Approved: March 17, 2010 Now Approved: Differin Lotion Differin Drug Information: http://www.drugs.com/differin.html Press Release: http://www.drugs.com/newdrugs/galderma-received-fda-approval-differin-adapalene-lotion-0-1-first-retinoid-available-lotion-2069.html Trelstar (triptorelin pamoate) Injection http://www.drugs.com/mtm/triptorelin.html New Formulation Approved: March 10, 2010 Now Approved: Trelstar 22.5 mg 6-Month Formulation Trelstar Drug Information: http://www.drugs.com/mtm/triptorelin.html Press Release: http://www.drugs.com/newdrugs/fda-approves-watson-s-trelstar-22-5-mg-first-only-6-month-intramuscular-gnrh-agonist-palliative-2041.html Xifaxan (rifaximin) Tablets http://www.drugs.com/xifaxan.html New Indication Approved: March 24, 2010 Now Approved for: Hepatic Encephalopathy Xifaxan Drug Information: http://www.drugs.com/xifaxan.html Press Release: http://www.drugs.com/newdrugs/fda-approves-new-xifaxan-patients-liver-2078.html Mirapex (pramipexole dihydrochloride) http://www.drugs.com/mirapex.html New Indication Approved: March 19, 2010 Now Approved: Mirapex ER for Both Early and Advanced Parkinson's Disease Mirapex Drug Information: http://www.drugs.com/mirapex.html Press Release: http://www.drugs.com/newdrugs/once-daily-mirapex-er-now-approved-fda-both-early-advanced-parkinson-s-2073.html Botox (onabotulinumtoxinA) Injection http://www.drugs.com/botox.html New Indication Approved: March 9, 2010 Now Approved for: Upper Limb Spasticity Botox Drug Information: http://www.drugs.com/botox.html Press Release: http://www.drugs.com/newdrugs/botox-onabotulinumtoxina-receives-fda-approval-upper-limb-spasticity-adults-2039.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. Desloratadine Tablets 5 mg Approved: February 19, 2010 Company: Orchid Healthcare Generic for: Clarinex Tablets Imiquimod Cream 5% Approved: February 25, 2010 Company: Nycomed US, Inc. Generic for: Aldara Cream Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Asclera Approved to Treat Varicose Veins http://www.drugs.com/news/asclera-approved-varicose-veins-23527.html Many Kids Not Fully Informed of Their Role in Cancer Studies http://www.drugs.com/news/many-kids-not-fully-informed-their-role-cancer-studies-23486.html Optimism May Boost Immune System http://www.drugs.com/news/optimism-may-boost-immune-23417.html Topical Drugs May Pollute Waterways http://www.drugs.com/news/topical-may-pollute-waterways-23409.html Abbreviated Trials Yield Misleading Results: Study http://www.drugs.com/news/abbreviated-trials-yield-misleading-results-study-23372.html Light Drinking Good for the Heart http://www.drugs.com/news/light-drinking-good-heart-23348.html Pesticide Labels Too Vague http://www.drugs.com/news/pesticide-labels-vague-23342.html Measles Outbreak Triggered by Unvaccinated Child http://www.drugs.com/news/measles-outbreak-triggered-unvaccinated-child-23327.html FDA Asks Consumers To Submit Questions As Part Of Transparency Plan http://www.drugs.com/news/fda-asks-consumers-submit-questions-part-transparency-plan-23271.html Blood Vessels Bounce Back Once Smokers Quit http://www.drugs.com/news/blood-vessels-bounce-back-once-smokers-quit-23244.html Medicine's Future Could Lie in Each Patient's Genome http://www.drugs.com/news/medicine-s-future-could-lie-each-patient-s-genome-23149.html Kids Who Get Flu Shots Protect the Unvaccinated http://www.drugs.com/news/kids-flu-shots-protect-unvaccinated-23096.html Parents Still Worried About Vaccine Safety http://www.drugs.com/news/parents-still-worried-vaccine-safety-22924.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review http://www.drugs.com/fda/stalevo-entacapone-carbidopa-levodopa-ongoing-safety-review-12714.html FDA and Natural Wellness Warn MasXtreme Capsules Contain Undeclared Drug Ingredient http://www.drugs.com/fda/masxtreme-capsules-natural-wellness-product-contains-undeclared-ingredient-12713.html FDA Recommends Healthcare Professionals Temporarily Suspend Use of Rotarix http://www.drugs.com/fda/rotarix-vaccine-update-clinicians-public-health-professionals-12712.html FDA Warns of Increased Risk of Muscle Injury with High Doses of Zocor (simvastatin) http://www.drugs.com/fda/zocor-simvastatin-increased-risk-muscle-injury-doses-12711.html Update: Recall - Cleviprex (clevidipine butyrate) http://www.drugs.com/fda/cleviprex-clevidipine-butyrate-recall-12709.html Boxed Warning for Plavix (clopidogrel) http://www.drugs.com/fda/plavix-clopidogrel-reduced-effectiveness-patients-poor-metabolizers-12705.html Oral Bisphosphonates: Ongoing Safety Review http://www.drugs.com/fda/oral-bisphosphonates-ongoing-safety-review-atypical-subtrochanteric-femur-fractures-12703.html Boxed Warning for WinRho SDF (Rho(D) Immune Globulin Intravenous (Human) http://www.drugs.com/fda/winrho-sdf-rho-d-immune-globulin-intravenous-human-risk-intravascular-hemolysis-12700.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 - 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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