Drugs.com Newsletter Vol 71 - July 2010 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- H1N1 Protection in Coming Season's Flu Vaccines: FDA July 2010 - The flu vaccines approved for the 2010-11 season protect against three strains of influenza, including the 2009 H1N1 pandemic swine flu strain, the United States Food and Drug Administration has announced Read more: http://www.drugs.com/news/h1n1-protection-coming-season-s-flu-vaccines-fda-25864.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Cuvposa (glycopyrrolate) Oral Solution http://www.drugs.com/cuvposa.html Date of Approval: July 28, 2010 Treatment for: Chronic Drooling in Children Cuvposa Drug Information: http://www.drugs.com/cuvposa.html Press Release: http://www.drugs.com/newdrugs/fda-approves-cuvposa-chronic-drooling-children-2227.html Tribenzor (amlodipine, hydrochlorothiazide and olmesartan) Tablets http://www.drugs.com/tribenzor.html Date of Approval: July 23, 2010 Treatment for: Hypertension Tribenzor Drug Information: http://www.drugs.com/tribenzor.html Press Release: http://www.drugs.com/newdrugs/fda-approves-tribenzor-new-three-one-combination-product-blood-pressure-2225.html Veltin (clindamycin and tretinoin) Gel http://www.drugs.com/veltin.html Date of Approval: July 16, 2010 Treatment for: Acne Veltin Drug Information: http://www.drugs.com/veltin.html Press Release: http://www.drugs.com/newdrugs/stiefel-gsk-receives-fda-approval-veltin-clindamycin-phosphate-tretinoin-gel-1-2-0-025-2220.html Zuplenz (ondansetron) Oral Soluble Film http://www.drugs.com/zuplenz.html Date of Approval: July 2, 2010 Treatment for: Prevention of Chemotherapy-Induced, Radiotherapy-Induced, and Postoperative Nausea and Vomiting Zuplenz Drug Information: http://www.drugs.com/zuplenz.html Press Release: http://www.drugs.com/newdrugs/fda-approves-strativa-pharmaceuticals-zuplenz-ondansetron-oral-soluble-film-2208.html Glassia (alpha1-proteinase inhibitor (human)) Injection http://www.drugs.com/glassia.html Date of Approval: July 1, 2010 Treatment for: Alpha-1 Proteinase Inhibitor Deficiency Glassia Drug Information: http://www.drugs.com/glassia.html Press Release: http://www.drugs.com/newdrugs/kamada-wins-fda-approval-glassia-new-liquid-ready-alpha-1-antitrypsin-deficiency-2209.html Butrans (buprenorphine) Transdermal System http://www.drugs.com/butrans.html Date of Approval: June 30, 2010 Treatment for: Pain Butrans Drug Information: http://www.drugs.com/butrans.html Press Release: http://www.drugs.com/newdrugs/purdue-pharma-l-p-receives-fda-approval-butrans-buprenorphine-transdermal-ciii-2202.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Simcor (niacin ER and simvastatin) Tablets http://www.drugs.com/simcor.html New Dosage Form Approved: July 28, 2010 Now Approved: 500 mg/40 mg and 1000 mg/40 mg Strengths Simcor Drug Information: http://www.drugs.com/simcor.html Press Release: http://www.drugs.com/newdrugs/abbott-s-simcor-niacin-extended-release-simvastatin-receives-fda-approval-new-2229.html Aricept (donepezil) http://www.drugs.com/aricept.html New Dosage Form Approved: July 23, 2010 Now Approved: Aricept 23 mg Tablets Aricept Drug Information: http://www.drugs.com/aricept.html Press Release: http://www.drugs.com/newdrugs/eisai-inc-pfizer-inc-announce-u-s-fda-approval-new-higher-aricept-donepezil-hcl-23-mg-tablet-2224.html Daytrana (methylphenidate) Transdermal System http://www.drugs.com/daytrana.html Patient Population Altered: June 29, 2010 Now Approved for: Treatment of ADHD in Adolescents Daytrana Drug Information: http://www.drugs.com/daytrana.html Press Release: http://www.drugs.com/newdrugs/fda-approves-daytrana-methylphenidate-transdermal-cii-adhd-adolescents-2211.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.Chlorzoxazone Tablets USP, 375 mg and 750 mg Approved: June 1, 2010 - Mikart Inc. Generic for: Parafon Forte DSC CapletsAdapalene Gel 0.1% Approved: June 2, 2010 - Pliva Hrvatska D.O.O. Generic for: Differin GelMiconazole Nitrate Vaginal Insert & Miconazole Nitrate Cream 1200 mg/2% Approved: June 2, 2010 - Perrigo R&D Company Generic for: Monistat 1 Combination PackOxymorphone Hydrochloride Extended-Release Tablets 5 mg, 10 mg, 20 mg and 40 mg Approved: June 14, 2010 - Impax Laboratories, Inc. Generic for: Opana ER TabletsArticaine Hydrochloride and Epinephrine Injection 4%/1:100,000 (Dental Cartridge) Approved: June 18, 2010 - Hospira Inc. Generic for: Septocaine and Epinephrine Injection (4%/1:100,000)Meropenem for Injection USP, 500 mg/vial and 1 g/vial Approved: June 22, 2010 - Hospira, Inc. Generic for: Merrem I.V. for InjectionAnastrozole Tablets 1 mg Approved: June 28, 2010 - Accord Healthcare Inc., USA; Natco Pharma Limited; Sandoz Inc.;Stason Pharmaceuticals, Inc.; Mylan Pharmaceuticals, Inc.; Zydus Pharmaceuticals USA, Inc.; Three Rivers Pharmaceuticals, LLC; Fresenius Kabi Oncology plc;Synthon Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Watson Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd. Generic for: Arimidex TabletsVenlafaxine Hydrochloride Extended-Release Capsules 37.5 mg (base), 75 mg (base) and 150 mg (base) Approved: June 28, 2010 - Teva Pharmaceuticals USA Generic for: Effexor XR CapsulesAdapalene Cream 0.1% Approved: June 30, 2010 - Nycomed US, Inc. Generic for: Differin Cream Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Not All Epilepsy Drugs Raise Suicide Risk: Study http://www.drugs.com/news/not-all-epilepsy-raise-suicide-risk-study-25760.html Stroke Prevention Treatment Varies Widely Across U.S. http://www.drugs.com/news/stroke-prevention-varies-widely-across-u-s-25761.html Sunscreen Concerns Unfounded, Experts Say http://www.drugs.com/news/sunscreen-concerns-unfounded-experts-say-25751.html Avoid Mosquito Bites to Prevent Dengue Fever in Florida: Expert http://www.drugs.com/news/avoid-mosquito-bites-prevent-dengue-fever-florida-expert-25735.html Giving Kids Booze, Medicines Can Be Child Abuse http://www.drugs.com/news/giving-kids-booze-medicines-can-child-abuse-25693.html Moderate Caffeine Intake Safe During Pregnancy, Experts Say http://www.drugs.com/news/moderate-caffeine-intake-safe-during-pregnancy-experts-say-25683.html Researchers Use Ecstasy to Treat PTSD http://www.drugs.com/news/researchers-ecstasy-ptsd-25615.html More Americans Abusing Prescription Painkillers http://www.drugs.com/news/more-americans-abusing-painkillers-25570.html Diabetics Urged to Confer With Their Doctor About Avandia Use http://www.drugs.com/news/diabetics-urged-confer-their-doctor-avandia-25572.html Experts Issue New Guidelines on Breast Cancer Drugs http://www.drugs.com/news/experts-issue-new-guidelines-breast-cancer-25499.html Antibiotic May Up Risk of Dangerous Potassium Levels in Seniors http://www.drugs.com/news/antibiotic-may-up-risk-dangerous-potassium-levels-seniors-25336.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Recall: Nutraloid Labs ejaculoid XXTREME and stimuloid II - Undeclared Drug Ingredient http://www.drugs.com/fda/nutraloid-labs-ejaculoid-xxtreme-stimuloid-ii-undeclared-ingredient-12774.html FDA Warns of Serious Harm from Consuming Miracle Mineral Solution (MMS) http://www.drugs.com/fda/miracle-mineral-solution-mms-product-consumed-produces-potent-bleach-12773.html FDA Updates Warnings and Precautions for Afluria (CSL Ltd.) Influenza Virus Vaccine http://www.drugs.com/fda/afluria-csl-ltd-influenza-virus-vaccine-label-change-risk-fever-febrile-seizure-12772.html FDA Warns of Eosinophilic Pneumonia Risk with Cubicin (daptomycin) http://www.drugs.com/fda/cubicin-daptomycin-safety-communication-risk-eosinophilic-pneumonia-12771.html FDA Advisory: Avoid Unintentional Exposure of Children and Pets to Evamist http://www.drugs.com/fda/evamist-estradiol-transdermal-safety-communication-unintended-exposure-children-pets-topical-12770.html Advair Diskus Stolen Product Warning http://www.drugs.com/fda/advair-diskus-fluticasone-propionate-salmeterol-inhalation-powder-stolen-product-warning-12763.html Angiotensin Receptor Blockers: Ongoing Safety Review for Cancer Risk http://www.drugs.com/fda/angiotensin-receptor-blockers-arbs-ongoing-safety-review-cancer-risk-12762.html Recall: Coumadin 1 mg Tablet Blister Packs http://www.drugs.com/fda/coumadin-1-mg-tablet-blister-packs-recall-12761.html Boxed Warning for Arava (leflunomide) - Risk of Severe Liver Injury http://www.drugs.com/fda/arava-leflunomide-boxed-warning-risk-severe-liver-injury-12760.html Recall: McNeil Consumer Healthcare Over-The-Counter Products (Updated) http://www.drugs.com/fda/mcneil-consumer-healthcare-over-counter-products-recall-12759.html FDA Warns Against "Off-Label" Use of Qualaquin http://www.drugs.com/fda/qualaquin-quinine-sulfate-new-risk-evaluation-mitigation-strategy-risk-serious-hematological-12757.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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