Drugs.com Newsletter Vol 62 - October 2009 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- 1 Million More Doses of Swine Flu Vaccine on Hand October 2009 - U.S. officials reported Wednesday the addition of another million doses H1N1 swine flu vaccine, bringing the total so far to 23 million doses Read more: http://www.drugs.com/news/1-million-more-doses-of-swine-flu-vaccine-on-hand-20605.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Arzerra (ofatumumab) Injection http://www.drugs.com/arzerra.html Date of Approval: October 26, 2009 Treatment for: Chronic Lymphocytic Leukemia Arzerra Drug Information: http://www.drugs.com/arzerra.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-arzerra-ofatumumab-for-chronic-lymphocytic-leukemia-1750.html Votrient (pazopanib) Tablets http://www.drugs.com/votrient.html Date of Approval: October 19, 2009 Treatment for: Renal Cell Carcinoma Votrient Drug Information: http://www.drugs.com/votrient.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-glaxosmithkline-s-votrient-for-advanced-renal-cell-cancer-1696.html Twynsta (telmisartan and amlodipine) Tablets http://www.drugs.com/twynsta.html Date of Approval: October 16, 2009 Treatment for: Hypertension Twynsta Drug Information: http://www.drugs.com/twynsta.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-twynsta-telmisartan-amlodipine-for-hypertension-1693.html Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) Injection http://www.drugs.com/cervarix.html Date of Approval: October 16, 2009 Treatment for: Human Papillomavirus Prophylaxis Cervarix Drug Information: http://www.drugs.com/cervarix.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-cervarix-glaxosmithkline-s-cervical-cancer-vaccine-1690.html Berinert (C1 esterase inhibitor (human)) Injection http://www.drugs.com/berinert.html Date of Approval: October 9, 2009 Treatment for: Angioedema Berinert Drug Information: http://www.drugs.com/berinert.htmlnPress Release: http://www.drugs.com/newdrugs/csl-behring-announces-fda-approval-of-berinert-first-and-only-therapy-approved-for-the-treatment-of-acute-abdominal-and-facial-attacks-of-hereditary-angioedema-in-u-s-1681.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Colcrys (colchicine) Tablets http://www.drugs.com/colcrys.html New Indication Approved: October 16, 2009 Now Approved for: Prevention of Gout Colcrys Drug Information: http://www.drugs.com/colcrys.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-colcrys-colchicine-usp-for-prevention-of-gout-flares-1721.html Micardis (telmisartan) Tablets http://www.drugs.com/micardis.html New Indication Approved: October 16, 2009 Now Approved for: Cardiovascular Risk Reduction Micardis Drug Information: http://www.drugs.com/micardis.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-new-use-for-micardis-in-cardiovascular-risk-reduction-1698.html Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) Injection http://www.drugs.com/gardasil.html New Indication Approved: October 16, 2009 Now Approved for: Prevention of Genital Warts Caused by HPV in Boys and Young Men Gardasil Drug Information: http://www.drugs.com/gardasil.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-gardasil-for-use-in-boys-and-young-men-1691.html Mirena (levonorgestrel) Intrauterine System http://www.drugs.com/mirena.html New Indication Approved: October 1, 2009 Now Approved for: Heavy Menstrual Bleeding in IUD Users Mirena Drug Information: http://www.drugs.com/mirena.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-additional-use-for-iud-mirena-to-treat-heavy-menstrual-bleeding-in-iud-users-1670.html Fluarix (influenza virus vaccine, inactivated) http://www.drugs.com/fluarix.html Patient Population Altered: October 19, 2009 Now Approved for: Children ages 3 years to 17 years Fluarix Drug Information: http://www.drugs.com/fluarix.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-seasonal-influenza-vaccine-fluarix-for-pediatric-use-1695.html Elitek (rasburicase) Injection http://www.drugs.com/mtm/elitek.html Patient Population Altered: October 16, 2009 Now Approved for: Adult Patients Elitek Drug Information: http://www.drugs.com/mtm/elitek.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-elitek-rasburicase-for-management-of-plasma-uric-acid-levels-in-adults-with-leukemia-lymphoma-and-solid-tumors-receiving-anti-cancer-therapy-1692.html Crestor (rosuvastatin calcium) Tablets http://www.drugs.com/crestor.html Patient Population Altered: October 15, 2009 Now Approved for: Pediatric Patients Crestor Drug Information: http://www.drugs.com/crestor.htmlnPress Release: http://www.drugs.com/newdrugs/u-s-food-and-drug-administration-approves-crestor-for-use-in-pediatric-patients-with-heterozygous-familial-hypercholesterolemia-1687.html Welchol (colesevelam HCl) Tablets and Oral Suspension http://www.drugs.com/mtm/welchol.html Patient Population Altered: October 2, 2009 Now Approved for: Pediatric Patients with Heterozygous Familial Hypercholesterolemia Welchol Drug Information: http://www.drugs.com/mtm/welchol.htmlnPress Release: http://www.drugs.com/newdrugs/welchol-colesevelam-hcl-receives-fda-approval-to-lower-ldl-cholesterol-in-pediatric-patients-with-heterozygous-familial-hypercholesterolemia-1679.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. Norethindrone Acetate & Ethinyl Estradiol Tablets USP, & Fe 1 mg/0.02 mg with 75 mg Ferrous Fumarate (24-Day Regimen) Approved: September 1, 2009 Watson Laboratotries, Inc. Generic for: Loestrin 24 Fe Tablets Temazepam Capsules USP, 7.5 mg Approved: September 8, 2009 Mutual Pharmaceutical Company, Inc. Generic for: Restoril Capsules 7.5 mg Nateglinide Tablets 60 mg and 120 mg Approved: September 9, 2009 Par Pharmaceutical, Inc.; Dr. Reddy's Laboratories; Teva Pharmaceuticals USA Generic for: Starlix Tablets Piperacillin and Tazobactam for Injection 36 g (base)/4.5 g (base)/vial, (pharmacy bulk package) Approved: September 15, 2009 Orchid Healthcare Generic for: Zosyn for Injection (Pharmacy Bulk Package) Piperacillin and Tazobactam for Injection 2 g (base)/250 mg (base)/vial, 3 g (base)/375 mg (base)/vial and 4 g (base)/500 mg (base)/vial Approved: September 15, 2009 Orchid Healthcare Generic for: Zosyn for Injection Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Mapping the Link Between Alcohol, Cancer http://www.drugs.com/news/mapping-the-link-between-alcohol-cancer-20577.html Changing Behavior Helps Patients Take Medication as Prescribed http://www.drugs.com/news/changing-behavior-helps-patients-take-medication-as-prescribed-20571.html HPV Vaccine No More Painful Than Other Shots http://www.drugs.com/news/hpv-vaccine-no-more-painful-than-other-shots-20535.html Drug Use in Teens May Damage Memory Years Later http://www.drugs.com/news/drug-use-in-teens-may-damage-memory-years-later-20501.html Worldwide Vaccine Availability Reaches All-Time High: Report http://www.drugs.com/news/worldwide-vaccine-availability-reaches-all-time-high-report-20475.html Full Results of AIDS Vaccine Trial Confirm Modest Benefit http://www.drugs.com/news/full-results-of-aids-vaccine-trial-confirm-modest-benefit-20451.html Drinking Your Way to Health? Perhaps Not http://www.drugs.com/news/drinking-your-way-to-health-perhaps-not-20418.html Bad Reaction No Good Reason to Avoid Future Shots http://www.drugs.com/news/bad-reaction-no-good-reason-to-avoid-future-shots-20381.html New FDA Web Page Lists Disposal Instructions for Select Medicines http://www.drugs.com/news/new-fda-web-page-lists-disposal-instructions-for-select-medicines-20370.html Stop-Smoking Vaccine in the Works http://www.drugs.com/news/stop-smoking-vaccine-in-the-works-20310.html In Health Care Today, It's Electronic All the Way http://www.drugs.com/news/in-health-care-today-it-s-electronic-all-the-way-20185.html Children Need Seasonal Flu Vaccine, Experts Say http://www.drugs.com/news/children-need-seasonal-flu-vaccine-experts-say-20156.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall http://www.drugs.com/fda/accusure-insulin-syringes-qualitest-pharmaceuticals-recall-12623.html FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir http://www.drugs.com/fda/peramivir-iv-12622.html Rituxan (rituximab) - Third Case of PML Reported http://www.drugs.com/fda/rituxan-rituximab-pml-12621.html American Regent - Voluntary Recall of Ketorolac Tromethamine Injection http://www.drugs.com/fda/ketorolac-tromethamine-injection-usp-30-mg-ml-1ml-and-2ml-single-dose-vials-recall-12620.html Dexferrum (iron dextran injection) Labeling Changed to Warn of Severe Allergic Reactions http://www.drugs.com/fda/dexferrum-iron-dextran-injection-labeling-change-12616.html FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet http://www.drugs.com/fda/tamiflu-oseltamivir-for-oral-suspension-12615.html GSK and FDA Warn Against Nebulization of Relenza (zanamivir) Inhalation Powder http://www.drugs.com/fda/relenza-zanamivir-inhalation-powder-12613.html FDA Announces Change in USP Reference Standard for Heparin http://www.drugs.com/fda/heparin-change-in-reference-standard-12609.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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