Drugs.com Newsletter Vol 63 - November 2009 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- Diabetes Cases Expected to Double in 25 Years November 2009 - The number of people with diabetes in the United States is expected to double over the next 25 years, a new study predicts Read more: http://www.drugs.com/news/diabetes-cases-expected-double-25-years-21154.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Qutenza (capsaicin) Transdermal Patch http://www.drugs.com/qutenza.html Date of Approval: November 16, 2009 Treatment for: Postherpetic Neuralgia Qutenza Drug Information: http://www.drugs.com/qutenza.html Press Release: http://www.drugs.com/newdrugs/neurogesx-receives-fda-approval-qutenza-capsaicin-8-patch-postherpetic-neuralgia-phn-1772.html Lysteda (tranexamic acid) Tablets http://www.drugs.com/lysteda.html Date of Approval: November 13, 2009 Treatment for: Menorrhagia Lysteda Drug Information: http://www.drugs.com/lysteda.html Press Release: http://www.drugs.com/newdrugs/xanodyne-announces-fda-approval-lysteda-tranexamic-acid-women-heavy-menstrual-bleeding-1771.html Istodax (romidepsin) for Injection http://www.drugs.com/istodax.html Date of Approval: November 5, 2009 Treatment for: Cutaneous T-cell Lymphoma Istodax Drug Information: http://www.drugs.com/istodax.html Press Release: http://www.drugs.com/newdrugs/fda-approves-gloucester-pharmaceuticals-istodax-patients-cutaneous-t-cell-lymphoma-1762.html Pennsaid (diclofenac sodium) Topical Solution http://www.drugs.com/pennsaid.html Date of Approval: November 4, 2009 Treatment for: Osteoarthritis Pennsaid Drug Information: http://www.drugs.com/pennsaid.html Press Release: http://www.drugs.com/newdrugs/fda-approves-pennsaid-topical-solution-1758.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Revatio (sildenafil citrate) http://www.drugs.com/revatio.html New Dosage Form Approved: November 18, 2009 Now Approved: Revatio Injection Revatio Drug Information: http://www.drugs.com/revatio.html Press Release: http://www.drugs.com/newdrugs/fda-approves-intravenous-formulation-pfizer-s-revatio-sildenafil-pulmonary-arterial-hypertension-1781.html Abilify (aripiprazole) http://www.drugs.com/abilify.html New Indication Approved: November 19, 2009 Now Approved for: Irritability Associated with Autistic Disorder in Pediatric Patients Abilify Drug Information: http://www.drugs.com/abilify.html Press Release: http://www.drugs.com/newdrugs/u-s-food-administration-approves-abilify-aripiprazole-irritability-associated-autistic-disorder-1783.html Byetta (exenatide) Injection http://www.drugs.com/byetta.html New Indication Approved: November 2, 2009 Now Approved for: Type 2 Diabetes Monotherapy Byetta Drug Information: http://www.drugs.com/byetta.html Press Release: http://www.drugs.com/newdrugs/byetta-approved-expanded-first-line-type-2-diabetes-1755.html Influenza A (H1N1) 2009 Monovalent Vaccine http://www.drugs.com/Influenza-A-H1N1-2009-Monovalent-Vaccine.html Patient Population Altered: November 10, 2009 Now Approved for: Childen 6 Months and Older 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-expands-approved-h1n1-vaccines-include-infants-children-1768.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. Buprenorphine Hydrochloride Sublingual Tablets 2 mg (base) and 8 mg (base) Approved: October 8, 2009 Roxane Laboratories, Inc. Generic for: Subutex Chlorothiazide Sodium for Injection, USP 500 mg (base)/vial Approved: October 16, 2009 APP Pharmaceuticals, Inc. Generic for: Diuril for Injection Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Implantable Cancer Vaccine Shows Promise http://www.drugs.com/news/implantable-cancer-vaccine-shows-promise-21141.html One Step Closer to New Diabetes Treatment http://www.drugs.com/news/one-step-closer-new-diabetes-treatment-21136.html Some Prescription Meds May Raise Seniors' Risks of Falling http://www.drugs.com/news/some-meds-may-raise-seniors-risks-falling-21125.html Ginkgo Won't Prevent Heart Attack, Stroke in Elderly http://www.drugs.com/news/ginkgo-won-t-prevent-heart-attack-stroke-elderly-21124.html Sleep Disorders Plague Cancer Patients http://www.drugs.com/news/sleep-disorders-plague-cancer-patients-21087.html Vioxx Problems Known Years Before Recall http://www.drugs.com/news/vioxx-problems-known-years-before-recall-21089.html Three-Month Supply Lowers Drug Costs http://www.drugs.com/news/three-month-supply-lowers-costs-21052.html WHO: Swine Flu Shot Not Causing Deaths http://www.drugs.com/news/who-swine-flu-shot-not-causing-deaths-21022.html Vaccines on Horizon for AIDS, Alzheimer's, Herpes http://www.drugs.com/news/vaccines-horizon-aids-alzheimer-s-herpes-20986.html Heartburn Drugs Can Thwart Popular Blood Thinner http://www.drugs.com/news/heartburn-can-thwart-popular-blood-thinner-20981.html Sharing Prescriptions Can Bring Harm, Not Healing http://www.drugs.com/news/sharing-prescriptions-can-bring-harm-not-healing-20848.html FDA Initiative Seeks to Reduce Accidental Overdoses http://www.drugs.com/news/fda-initiative-seeks-reduce-accidental-overdoses-20739.html Nicotine Patch Plus Lozenge Best for Quitting Smoking http://www.drugs.com/news/nicotine-patch-plus-lozenge-best-quitting-smoking-20696.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review http://www.drugs.com/fda/meridia-sibutramine-hydrochloride-early-communication-ongoing-safety-review-12648.html Recall - Vicks Sinex Nasal Spray http://www.drugs.com/fda/vicks-sinex-nasal-recall-12647.html FDA Warns of Drug Interactions between Plavix and Prilosec http://www.drugs.com/fda/clopidogrel-marketed-plavix-omeprazole-marketed-prilosec-interaction-12645.html Recall - IDS Sports Dietary Supplements http://www.drugs.com/fda/ids-sports-dietary-supplements-recall-12644.html FDA Warns of Potential for Foreign Particle Contamination in Several Genzyme Products http://www.drugs.com/fda/genzyme-products-marketed-cerezyme-fabrayzme-myozyme-aldurazyme-thyrogen-12639.html FDA Warns of Chondrolysis Reports in Patients Given Continuous Intra-Articular Infusions of Local Anesthetics http://www.drugs.com/fda/local-anesthetics-continuously-infused-marketed-bupivacaine-chloroprocaine-lidocaine-mepivacaine-12638.html Recall - Dietary Supplement Marketed as Pai You Guo http://www.drugs.com/fda/pai-you-guo-marketed-dietary-supplement-recall-12637.html Hospira Brand Propofol and Liposyn Products - Recall http://www.drugs.com/fda/hospira-brand-propofol-liposyn-products-recall-12632.html Nationwide and International Recall of Bodybuilding.com Brand Dietary Supplements http://www.drugs.com/fda/bodybuilding-brand-dietary-supplements-sold-internet-12630.html Byetta Label Revised to Include Safety Information on Possible Kidney Problems http://www.drugs.com/fda/byetta-exenatide-renal-failure-12626.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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