Drugs.com Newsletter Vol 59 - July 2009 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- Pregnant Women, Health-Care Workers Top Swine Flu Vaccine Candidates July 2009 - Women who are pregnant, children six months and older, and health care workers should all get top priority when the H1N1 swine flu vaccine arrives this fall, a United States government advisory panel has recommended Read more: http://www.drugs.com/news/pregnant-women-health-care-workers-top-swine-flu-vaccine-candidates-19078.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Acuvail (ketorolac tromethamine) Ophthalmic Solution http://www.drugs.com/acuvail.html Date of Approval: July 22, 2009 Treatment for: Postoperative Ocular Inflammation Acuvail Drug Information: http://www.drugs.com/acuvail.html Press Release: http://www.drugs.com/newdrugs/allergan-receives-fda-approval-for-acuvail-ophthalmic-solution-for-the-treatment-of-pain-and-inflammation-following-cataract-surgery-1514.html Onsolis (fentanyl) Buccal Soluble Film http://www.drugs.com/onsolis.html Date of Approval: July 16, 2009 Treatment for: Pain Onsolis Drug Information: http://www.drugs.com/onsolis.html Press Release: http://www.drugs.com/newdrugs/biodelivery-sciences-and-meda-announce-fda-approval-of-onsolis-1487.html Sumavel DosePro (sumatriptan) Injection http://www.drugs.com/Sumavel-DosePro.html Date of Approval: July 15, 2009 Treatment for: Migraine, Cluster Headache Sumavel DosePro Drug Information: http://www.drugs.com/Sumavel-DosePro.html Press Release: http://www.drugs.com/newdrugs/sumavel-dosepro-sumatriptan-injection-approved-by-fda-for-acute-migraine-and-cluster-headache-first-product-featuring-novel-dosepro-needle-free-delivery-system-1490.html Plan B One-Step (levonorgestrel) Tablet http://www.drugs.com/plan-b-one-step.html Date of Approval: July 10, 2009 Treatment for: Emergency Contraception Plan B One-Step Drug Information: http://www.drugs.com/plan-b-one-step.html Press Release: http://www.drugs.com/newdrugs/fda-approves-plan-b-one-step-a-new-one-pill-emergency-contraceptive-1486.html Effient (prasugrel) Tablets http://www.drugs.com/effient.html Date of Approval: July 10, 2009 Treatment for: Acute Coronary Syndrome Effient Drug Information: http://www.drugs.com/effient.html Press Release: http://www.drugs.com/newdrugs/daiichi-sankyo-and-lilly-receive-u-s-fda-approval-for-effient-1485.html Multaq (dronedarone) Tablets http://www.drugs.com/multaq.html Date of Approval: July 1, 2009 Treatment for: Atrial Fibrillation, Atrial Flutter Multaq Drug Information: http://www.drugs.com/multaq.html Press Release: http://www.drugs.com/newdrugs/fda-approves-multaq-for-patients-with-atrial-fibrillation-or-atrial-flutter-1483.html Feraheme (ferumoxytol) Intravenous Injection http://www.drugs.com/feraheme.html Date of Approval: June 30, 2009 Treatment for: Anemia Associated with Chronic Renal Failure Feraheme Drug Information: http://www.drugs.com/feraheme.html Press Release: http://www.drugs.com/newdrugs/fda-approves-feraheme-to-treat-iron-deficiency-anemia-in-adult-chronic-kidney-disease-patients-1482.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. NovoLog (insulin aspart) Injection http://www.drugs.com/novolog.html Expiration Date Change Approved: July 14, 2009 Now Approved: Six Day Storage in Insulin Pumps NovoLog Drug Information: http://www.drugs.com/novolog.html Press Release: http://www.drugs.com/newdrugs/fda-approves-novolog-labeling-update-1510.html Forteo (teriparatide (rDNA origin)) Injection http://www.drugs.com/forteo.html New Indication Approved: July 22, 2009 Now Approved for: Glucocorticoid-Induced Osteoporosis Forteo Drug Information: http://www.drugs.com/forteo.html Press Release: http://www.drugs.com/newdrugs/fda-approves-expanded-use-of-lilly-s-forteo-teriparatide-rdna-origin-injection-to-treat-glucocorticoid-induced-osteoporosis-1515.html Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets http://www.drugs.com/tekturna-hct.html New Indication Approved: July 16, 2009 Now Approved for: Initial Therapy of Hypertension Tekturna HCT Drug Information: http://www.drugs.com/tekturna-hct.html Press Release: http://www.drugs.com/newdrugs/fda-approves-tekturna-hct-as-initial-treatment-in-patients-unlikely-to-achieve-their-blood-pressure-goals-with-a-single-agent-1512.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. Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg; 0.215 mg/0.025 mg and 0.250 mg/0.025 mg (28-Day Regimen) Approved: June 29, 2009 Barr Laboratories, Inc. Generic for: Ortho Tri Cyclen Lo Oxcarbazepine Oral Suspension 300 mg/5 mL Approved: June 26, 2009 Ranbaxy Laboratories Limited Generic for: Trileptal Oral Suspension Levonorgestrel Tablets (Rx) 0.75 mg Approved: June 24, 2009 Watson Laboratories, Inc. Generic for: Plan B (levonorgestrel) Tablets, 0.75 mg Melphalan Hydrochloride for Injection 50 mg (base)/vial Approved: June 9, 2009 Synerx Pharma, LLC Generic for: Alkeran for Injection Omeprazole Magnesium Delayed-Release Capsules (OTC) 20 mg (base) Approved: June 6, 2009 Dr. Reddy's Laboratories Limited Generic for: Prilosec OTC Delayed-Release Capsules Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL; packaged in 40 mg/1 mL vials and 200 mg/5 mL and 400 mg/10 mL multiple-dose vials Approved: June 1, 2009 Sandoz Canada Inc. Generic for: Kenalog-40 Injectable Suspension Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Resistance to Malaria Drug Reported in Cambodia http://www.drugs.com/news/resistance-to-malaria-drug-reported-in-cambodia-19076.html Older Diabetics Should Avoid Dementia Meds http://www.drugs.com/news/older-diabetics-should-avoid-dementia-meds-19048.html More Can Be Done to Slow Obesity's Toll on Health: Experts http://www.drugs.com/news/more-can-be-done-to-slow-obesity-s-toll-on-health-experts-19050.html Blue Dye Halts Worsening Paralysis in Animal Study http://www.drugs.com/news/blue-dye-halts-worsening-paralysis-in-animal-study-19039.html Save Swine Flu Drugs for Younger Patients, Study Urges http://www.drugs.com/news/save-swine-flu-drugs-for-younger-patients-study-urges-19040.html Tight Management of Type 1 Diabetes Worth the Effort http://www.drugs.com/news/tight-management-of-type-1-diabetes-worth-the-effort-19034.html Giving Statins to Kids Provokes Debate http://www.drugs.com/news/giving-statins-to-kids-provokes-debate-19016.html Breast Cancer Drug May Beat Fungal Infection http://www.drugs.com/news/breast-cancer-drug-may-beat-fungal-infection-19012.html Injection May Heal Damaged Heart http://www.drugs.com/news/injection-may-heal-damaged-heart-18981.html Many Young Adults Uninformed About Vaccines http://www.drugs.com/news/many-young-adults-uninformed-about-vaccines-18964.html No Firm Evidence Green Tea Helps Prevent Cancer http://www.drugs.com/news/no-firm-evidence-green-tea-helps-prevent-cancer-18942.html High-Salt Diet Dampens Effects of Blood Pressure Drugs http://www.drugs.com/news/high-salt-diet-dampens-effects-of-blood-pressure-drugs-18918.html Internet May Be Newest Venue for Teen Tobacco Exposure http://www.drugs.com/news/internet-may-be-newest-venue-for-teen-tobacco-exposure-18912.html Hopes Dashed for Thalidomide as Lung Cancer Treatment http://www.drugs.com/news/hopes-dashed-for-thalidomide-as-lung-cancer-treatment-18859.html Educated Parkinson's Patients Move to Meds Sooner http://www.drugs.com/news/educated-parkinson-s-patients-move-to-meds-sooner-18823.html 'Easter Island' Drug Adds Years to Mice http://www.drugs.com/news/easter-island-drug-adds-years-to-mice-18714.html Anti-Smoking Drugs Get FDA 'Black-Box' Warning http://www.drugs.com/news/anti-smoking-drugs-get-fda-black-box-warning-18609.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Recall of Steam Dietary Supplement http://www.drugs.com/fda/steam-dietary-supplement-12570.html FDA Advises Against Using Body Building Products Containing Steroids or Steroid-like Substances http://www.drugs.com/fda/body-building-products-marketed-as-containing-steroids-or-steroid-like-substances-12569.html FDA Warns Against Using Electronic Cigarettes http://www.drugs.com/fda/electronic-cigarettes-12568.html Voluntary Recall of Weight Loss Products by Young You Corporation http://www.drugs.com/fda/weight-loss-products-by-young-you-corporation-12565.html Recall of Teva's Propofol Injectable Emulsion, 10 mg/mL 100 mL vials http://www.drugs.com/fda/propofol-injectable-emulsion-10-mg-ml-100-ml-vials-12564.html Voluntary Recall of Nature & Health Co. supplement products: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac http://www.drugs.com/fda/nature-health-co-supplement-products-libiextreme-y-4ever-libimax-x-liquid-powermania-liquid-and-capsule-herbal-disiac-12562.html Voluntary Recall of Concentrated Acetaminophen Drops http://www.drugs.com/fda/concentrated-acetaminophen-drops-12559.html FDA Requires Labeling Changes for Immunosuppressant Drugs http://www.drugs.com/fda/immunosuppressant-drugs-required-labeling-changes-12561.html Voluntary Recall of Libipower Plus http://www.drugs.com/fda/libipower-plus-12560.html Recall of Medtronic Paradigm Quick-Set Infusion Sets http://www.drugs.com/fda/medtronic-paradigm-quick-set-infusion-sets-12558.html Recall of Mallinckrodt Sodium Chromate Cr-51 Injection http://www.drugs.com/fda/mallinckrodt-sodium-chromate-cr-51-injection-12555.html Recall of Stealth Chocolate, Stealth Vanilla Powdered Dietary Supplement: Vital Pharmaceuticals Inc http://www.drugs.com/fda/stealth-chocolate-stealth-vanilla-powdered-dietary-supplement-vital-pharmaceuticals-inc-12557.html FDA Warns of Overdose Risk with Propoxyphene-containing Products http://www.drugs.com/fda/propoxyphene-containing-products-12554.html FDA Reviewing Safety Data for Lantus (insulin glargine) http://www.drugs.com/fda/lantus-insulin-glargine-12551.html More FDA Medwatch Alerts: http://www.drugs.com/fda_alerts.html TOOLS & HELPFUL LINKS --------------------- Community Discussion Forums - 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