Drugs.com Newsletter Vol 61 - September 2009 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- Could the Recession Be Good for Your Health? September 2009 - The economic downturn may not be all bad - in fact, researchers say recessions may actually be good for health Read more: http://www.drugs.com/news/could-the-recession-be-good-for-your-health-20111.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Stelara (ustekinumab) Injection http://www.drugs.com/stelara.html Date of Approval: September 25, 2009 Treatment for: Psoriasis Stelara Drug Information: http://www.drugs.com/stelara.html Press Release: http://www.drugs.com/newdrugs/fda-approves-stelara-ustekinumab-to-treat-psoriasis-1667.html Folotyn (pralatrexate) Injection http://www.drugs.com/folotyn.html Date of Approval: September 24, 2009 Treatment for: Peripheral T-cell Lymphoma Folotyn Drug Information: http://www.drugs.com/folotyn.html Press Release: http://www.drugs.com/newdrugs/fda-approves-folotyn-pralatrexate-for-treatment-of-peripheral-t-cell-lymphoma-1666.html Valturna (aliskiren and valsartan) Tablets http://www.drugs.com/valturna.html Date of Approval: September 16, 2009 Treatment for: Hypertension Valturna Drug Information: http://www.drugs.com/valturna.html Press Release: http://www.drugs.com/newdrugs/novartis-receives-fda-approval-for-valturna-a-single-pill-combination-of-valsartan-and-aliskiren-to-treat-high-blood-pressure-1656.html Influenza A (H1N1) 2009 Monovalent Vaccine http://www.drugs.com/Influenza-A-H1N1-2009-Monovalent-Vaccine.html Date of Approval: September 15, 2009 Treatment for: Prevention of H1N1 Influenza Influenza A (H1N1) 2009 Monovalent Vaccine Drug Information: http://www.drugs.com/Influenza-A-H1N1-2009-Monovalent-Vaccine.html Press Release: http://www.drugs.com/newdrugs/fda-approves-vaccines-for-2009-h1n1-influenza-virus-1653.html Zirgan (ganciclovir) Ophthalmic Gel http://www.drugs.com/zirgan.html Date of Approval: September 15, 2009 Treatment for: Herpetic Keratitis Zirgan Drug Information: http://www.drugs.com/zirgan.html Press Release: http://www.drugs.com/newdrugs/sirion-therapeutics-announces-fda-approval-of-zirgan-ganciclovir-ophthalmic-gel-0-15-for-herpetic-keratitis-1657.html Vibativ (telavancin) Injection http://www.drugs.com/vibativ.html Date of Approval: September 11, 2009 Treatment for: Complicated Skin and Skin Structure Infections (cSSSI) Vibativ Drug Information: http://www.drugs.com/vibativ.html Press Release: http://www.drugs.com/newdrugs/theravance-and-astellas-announce-fda-approval-of-vibativ-telavancin-for-the-treatment-of-complicated-skin-and-skin-structure-infections-1629.html Bepreve (bepotastine) Ophthalmic Solution http://www.drugs.com/bepreve.html Date of Approval: September 8, 2009 Treatment for: Allergic Conjunctivitis Bepreve Drug Information: http://www.drugs.com/bepreve.html Press Release: http://www.drugs.com/newdrugs/ista-pharmaceuticals-bepreve-receives-fda-approval-for-the-treatment-of-ocular-itching-due-to-allergies-1625.html Metozolv ODT (metoclopramide) Orally Disintegrating Tablets http://www.drugs.com/metozolv-odt.html Date of Approval: September 4, 2009 Treatment for: Gastroesophageal Reflux Disease, Gastroparesis Metozolv ODT Drug Information: http://www.drugs.com/metozolv-odt.html Press Release: http://www.drugs.com/newdrugs/salix-receives-fda-marketing-approval-for-metozolv-odt-orally-disintegrating-tablets-for-relief-of-diabetic-gastroparesis-and-symptomatic-documented-gerd-1623.html Intuniv (guanfacine) Extended Release Tablets http://www.drugs.com/intuniv.html Date of Approval: September 2, 2009 Treatment for: Attention-Deficit Hyperactivity Disorder Intuniv Drug Information: http://www.drugs.com/intuniv.html Press Release: http://www.drugs.com/newdrugs/shire-announces-fda-approval-of-once-daily-intuniv-guanfacine-extended-release-tablets-for-the-treatment-of-adhd-in-children-and-adolescents-aged-6-to-17-1599.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Astepro (azelastine) Nasal Spray http://www.drugs.com/astepro.html New Formulation Approved: August 31, 2009 Now Approved: Astepro Once-Daily Astepro Drug Information: http://www.drugs.com/astepro.html Press Release: http://www.drugs.com/newdrugs/meda-receives-fda-approval-of-new-astepro-azelastine-hcl-nasal-spray-0-15-the-first-and-only-once-daily-nasal-antihistamine-1577.html Zevalin (ibritumomab tiuxetan) Injection http://www.drugs.com/ppa/ibritumomab-tiuxetan.html New Indication Approved: September 3, 2009 Now Approved for: Previously Untreated Follicular non-Hodgkin's Lymphoma Zevalin Drug Information: http://www.drugs.com/ppa/ibritumomab-tiuxetan.html Press Release: http://www.drugs.com/newdrugs/fda-approves-zevalin-expanded-label-as-part-of-first-line-therapy-in-treatment-of-follicular-non-hodgkin-s-lymphoma-1602.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. Azelastine Hydrochloride Ophthalmic Solution 0.05% Approved: August 3, 2009 Apotex Inc. Generic for: Optivar Ophthalmic Solution Oxaliplatin Injection 5 mg/mL; (preservative-free), packaged in 50 mg/10 mL and 100 mg/20 mL single-use vials Approved: August 7, 2009 Hospira Worldwide; Sun Pharma Global; Fresenius Kabi Oncology Generic for: Eloxatin Injection Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg Approved: August 10, 2009 Sandoz, Inc. Generic for: Prograf Capsules Clindamycin Phosphate and Benzoyl Peroxide Gel 1% (base)/5% Approved: August 11, 2009 Dow Pharmaceutical Sciences, Inc. Generic for: Benzaclin Topical Gel Aspirin and Dipyridamole Extended-Release Capsules 25 mg/200 mg Approved: August 14, 2009 Barr Laboratories, Inc. Generic for: Aggrenox Extended-Release Capsules Clonidine Transdermal System USP 0.1 mg/day, 0.2 mg/day and 0.3 mg/day Approved: August 18, 2009 Aveva Drug Delivery Systems, Inc. Generic for: Catapres-TTS Levonorgestrel Tablets (Rx/OTC) 0.75 mg Approved: August 28, 2009 Watson Laboratories, Inc. Generic for: Plan B Tablets Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Many Kids Suffer Medication Side Effects: Study http://www.drugs.com/news/many-kids-suffer-medication-side-effects-study-20081.html Experimental AIDS Vaccine Delivers Good News http://www.drugs.com/news/experimental-aids-vaccine-delivers-good-news-20037.html Injectable Vaccines More Effective for Adult Flu Than Nasal Sprays http://www.drugs.com/news/injectable-vaccines-more-effective-for-adult-flu-than-nasal-sprays-20018.html Cost Savings Adds to Value of Preventing Chronic Disease http://www.drugs.com/news/cost-savings-adds-to-value-of-preventing-chronic-disease-19997.html Study Suggests a Wider Use for Statins http://www.drugs.com/news/study-suggests-a-wider-use-for-statins-19979.html Flavored Cigarette Ban Takes Effect http://www.drugs.com/news/flavored-cigarette-ban-takes-effect-19971.html Could Swine Flu Panic Be Worse Than Outbreak Itself? http://www.drugs.com/news/could-swine-flu-panic-be-worse-than-outbreak-itself-19961.html Progress Made Toward Vaccine for Urinary Infections http://www.drugs.com/news/progress-made-toward-vaccine-for-urinary-infections-19916.html More Teens Getting Needed Vaccines http://www.drugs.com/news/more-teens-getting-needed-vaccines-19909.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Voluntary Recall of Neocate Infant Specialized Formula http://www.drugs.com/fda/neocate-infant-specialized-formula-recall-12608.html FDA Warns of Potential Dosing Errors for Tamiflu (oseltamivir) for Oral Suspension http://www.drugs.com/fda/tamiflu-oseltamivir-for-oral-suspension-potential-medication-errors-12607.html Nationwide Recall of Children's and Infants' Tylenol Oral Suspension Products http://www.drugs.com/fda/children-s-and-infants-tylenol-oral-suspension-products-recall-12606.html FDA Revises Januvia/Janumet Prescribing Information to Include Reported Cases of Acute Pancreatitis http://www.drugs.com/fda/sitagliptin-marketed-as-januvia-and-janumet-acute-pancreatitis-12605.html FDA Reviewing Exjade (deferasirox) Safety Concerns http://www.drugs.com/fda/exjade-deferasirox-early-communication-12604.html FDA Reports PML Cases in Tysabri (natalizumab) Patients http://www.drugs.com/fda/natalizumab-marketed-as-tysabri-12599.html FDA Informs Pharmacists of Stolen Dey Labeled Albuterol Sulfate Inhalation Solution http://www.drugs.com/fda/albuterol-sulfate-inhalation-solution-unit-dose-vials-dey-lp-brand-12595.html GSK Warns Pure Red Cell Aplasia Reported in Patients Treated With Myfortic http://www.drugs.com/fda/myfortic-mycophenolic-acid-12590.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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