Drugs.com Newsletter Vol 69 - May 2010 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- FDA Announces Collaboration with Drugs.com May 2010 - The United States Food and Drug Administration has announced that it will collaborate with the Web site Drugs.com to expand access to the FDA's consumer health information. Drugs.com seeks to provide patients with information to better manage their own health care and to assist in the reduction of medication errors Read more: http://www.drugs.com/news/fda-announces-collaboration-24677.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Lumizyme (alglucosidase alfa) http://www.drugs.com/lumizyme.html Date of Approval: May 24, 2010 Treatment for: Pompe disease Lumizyme Drug Information: http://www.drugs.com/lumizyme.html Press Release: http://www.drugs.com/newdrugs/fda-approves-lumizyme-late-onset-pompe-2169.html Zymaxid (gatifloxacin) Ophthalmic Solution http://www.drugs.com/zymaxid.html Date of Approval: May 18, 2010 Treatment for: Bacterial Conjunctivitis Zymaxid Drug Information: http://www.drugs.com/zymaxid.html Press Release: http://www.drugs.com/newdrugs/allergan-receives-fda-approval-zymaxid-ophthalmic-solution-2167.html Sprix (ketorolac tromethamine) Nasal Spray http://www.drugs.com/sprix.html Date of Approval: May 14, 2010 Treatment for: Pain Sprix Drug Information: http://www.drugs.com/sprix.html Press Release: http://www.drugs.com/newdrugs/roxro-announces-fda-approval-sprix-2166.html Natazia (dienogest and estradiol valerate) http://www.drugs.com/natazia.html Date of Approval: May 6, 2010 Treatment for: Contraception Natazia Drug Information: http://www.drugs.com/natazia.html Press Release: http://www.drugs.com/newdrugs/fda-approves-natazia-new-combination-product-oral-contraceptive-2158.html Vimovo (naproxen and esomeprazole magnesium) http://www.drugs.com/vimovo.html Date of Approval: April 30, 2010 Treatment for: Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, NSAID-Induced Ulcer Prophylaxis Vimovo Drug Information: http://www.drugs.com/vimovo.html Press Release: http://www.drugs.com/newdrugs/fda-approved-vimovo-arthritis-patients-risk-developing-nsaid-associated-gastric-ulcers-2134.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. Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg and 100 mg/25 mg Approved: April 6, 2010 Teva Pharmaceuticals USA Generic for: Hyzaar Tablets Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/12.5 mg Approved: April 6, 2010 Roxane Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; Torrent Pharmaceuticals, Ltd.; Teva Pharmaceuticals USA Generic for: Hyzaar Tablets Losartan Potassium Tablets USP, 25 mg, 50 mg and 100 mg Approved: April 6, 2010 Teva Pharmaceuticals USA Generic for: Cozaar Tablets Memantine Hydrochloride Tablets 5 mg and 10 mg Approved: April 14, 2010 Dr. Reddy's Laboratories Limited Generic for: Namenda Tablets Imipramine Pamoate Capsules 75 mg, 100 mg, 125 mg and 150 mg Approved: April 14, 2010 Roxane Laboratories, Inc.; Lupin Limited Generic for: Tofranil-PM Capsules Amoxicillin & Clavulanate Potassium Extended-Release Tablets 1000 mg/62.5 mg (base) Approved: April 21, 2010 Sandoz Inc. Generic for: Augmentin XR Tablets Voriconazole Tablets 50 mg and 200 mg Approved: April 22, 2010 Matrix Laboratories Limited Generic for: Vfend Tablets Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Breast Cancer Vaccine Possible, Scientists Say http://www.drugs.com/news/breast-cancer-vaccine-possible-scientists-say-24718.html Many People Still Don't Know How to Protect Against Skin Cancer http://www.drugs.com/news/many-still-don-t-know-protect-against-skin-cancer-24684.html Many Supplements Said to Contain Toxins, Make False Health Claims http://www.drugs.com/news/many-supplements-said-contain-toxins-make-false-health-claims-24663.html 'The Pill' Is Birth Control Favorite in U.S. http://www.drugs.com/news/pill-birth-control-favorite-u-s-24662.html Heart Drugs Safe for Lungs, Study Finds http://www.drugs.com/news/heart-safe-lungs-study-finds-24608.html New Research: Kids' Consumption of Chronic Medications on the Rise http://www.drugs.com/news/new-research-kids-consumption-chronic-rise-24546.html Antibiotic Resistance Can Last a Year, Review Finds http://www.drugs.com/news/antibiotic-resistance-can-last-year-review-finds-24511.html Smallpox Vaccine May Protect Against HIV http://www.drugs.com/news/smallpox-vaccine-may-protect-against-hiv-24486.html Men, Women May Respond Differently to Vaccines http://www.drugs.com/news/men-women-may-respond-differently-vaccines-24478.html Rotavirus Vaccine Helps Kids Avoid Severe Gastro Illness http://www.drugs.com/news/rotavirus-vaccine-helps-kids-avoid-severe-gastro-illness-24444.html Herbal Supplements, Warfarin Can Be Hazardous Mix http://www.drugs.com/news/herbal-supplements-warfarin-can-hazardous-mix-24428.html Sugar Before Shots Helps Infants Cope http://www.drugs.com/news/sugar-before-shots-helps-infants-cope-24412.html Stomach Acid Drugs Come with Dangers, Studies Show http://www.drugs.com/news/stomach-acid-come-dangers-studies-show-24351.html Bar Codes Cut Down on Hospital Medication Errors http://www.drugs.com/news/bar-codes-cut-down-hospital-errors-24270.html Parent Error Common When Medicating Chronically Ill Kids http://www.drugs.com/news/parent-error-common-medicating-chronically-ill-kids-24187.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Recall: Hylenex recombinant (hyaluronidase human injection) http://www.drugs.com/fda/hylenex-recombinant-hyaluronidase-human-recall-12738.html New Warnings for Ultram and Ultracet http://www.drugs.com/fda/ultram-tramadol-hydrochloride-ultracet-tramadol-hydrochloride-acetaminophen-label-change-12737.html Labeling Change for Proton Pump Inhibitors http://www.drugs.com/fda/proton-pump-inhibitors-ppi-class-labeling-change-12736.html Voluntary Recall: Sagent Pharmaceuticals - Metronidazole injection 500 mg / 100 ml http://www.drugs.com/fda/metronidazole-500-mg-100-ml-voluntary-recall-due-non-sterility-12735.html Update: FDA Says Healthcare Providers Can Resume Use of Rotarix http://www.drugs.com/fda/rotarix-vaccine-update-clinicians-public-health-professionals-12734.html Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors http://www.drugs.com/fda/benadryl-extra-itch-stopping-gel-packaging-changes-reduce-errors-12733.html FDA and GSK Notify Healthcare Professionals of New Safety Finding for Promacta http://www.drugs.com/fda/promacta-eltrombopag-portal-venous-thromboses-study-patients-chronic-liver-12732.html Vivitrol: Medication Guide Required for Patients http://www.drugs.com/fda/vivitrol-naltrexone-extended-release-injectable-suspension-guide-required-patients-12728.html Warning: Vita Breath Dietary Supplement http://www.drugs.com/fda/vita-breath-dietary-supplement-12727.html GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer http://www.drugs.com/fda/gnrh-agonists-safety-review-class-prostate-cancer-12726.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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