Drugs.com Newsletter Vol 89 - January 2012 RSS News Feeds: http://www.drugs.com/rss.html You received this email because you are subscribed to updates from Drugs.com Change your notification settings or unsubscribe here: http://www.drugs.com/my_subscriptions.php?email=%PERS_EMAIL%&pid=%PERS_ID% FEATURED NEWS ------------- Monthly Roundup - January 2012 January 2012 - Bydureon Approved: First Once-A-Week Treatment for Type 2 Diabetes Amylin Pharmaceuticals received FDA-approval of Bydureon (exenatide extended-release for injectable suspension), a once-a-week, 2 mg injection used in conjunction with diet and exercise to improve glycemic control in type 2 diabetics Read more: http://www.drugs.com/news/monthly-roundup-january-2012-36173.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Kalydeco (ivacaftor) Tablets http://www.drugs.com/kalydeco.html Date of Approval: January 31, 2012 Treatment for: Cystic Fibrosis Kalydeco Drug Information: http://www.drugs.com/kalydeco.html Press Release: http://www.drugs.com/newdrugs/fda-approves-kalydeco-rare-cystic-fibrosis-3078.html Erivedge (vismodegib) Capsules http://www.drugs.com/erivedge.html Date of Approval: January 30, 2012 Treatment for: Basal Cell Carcinoma Erivedge Drug Information: http://www.drugs.com/erivedge.html Press Release: http://www.drugs.com/newdrugs/fda-approves-erivedge-basal-cell-carcinoma-3077.html Bydureon (exenatide) Extended-Release Injectable Suspension http://www.drugs.com/bydureon.html Date of Approval: January 27, 2012 Treatment for: Diabetes Mellitus Type II Bydureon Drug Information: http://www.drugs.com/bydureon.html Press Release: http://www.drugs.com/newdrugs/fda-approves-bydureon-first-only-once-weekly-type-2-diabetes-3073.html Inlyta (axitinib) Tablets http://www.drugs.com/inlyta.html Date of Approval: January 27, 2012 Treatment for: Renal Cell Carcinoma Inlyta Drug Information: http://www.drugs.com/inlyta.html Press Release: http://www.drugs.com/newdrugs/fda-approves-inlyta-advanced-renal-cell-carcinoma-3072.html Picato (ingenol mebutate) Topical Gel http://www.drugs.com/picato.html Date of Approval: January 23, 2012 Treatment for: Actinic Keratosis Picato Drug Information: http://www.drugs.com/picato.html Press Release: http://www.drugs.com/newdrugs/fda-approves-picato-ingenol-mebutate-gel-first-only-topical-actinic-keratosis-ak-therapy-2-3-3070.html Zetonna (ciclesonide) Nasal Aerosol http://www.drugs.com/zetonna.html Date of Approval: January 20, 2012 Treatment for: Allergic Rhinitis Zetonna Drug Information: http://www.drugs.com/zetonna.html Press Release: http://www.drugs.com/newdrugs/fda-approves-zetonna-ciclesonide-nasal-aerosol-allergic-rhinitis-3046.html Voraxaze (glucarpidase) Injection http://www.drugs.com/voraxaze.html Date of Approval: January 17, 2012 Treatment for: Toxic Methotrexate Levels Voraxaze Drug Information: http://www.drugs.com/voraxaze.html Press Release: http://www.drugs.com/newdrugs/fda-approves-voraxaze-patients-toxic-methotrexate-levels-3038.html Subsys (fentanyl) Sublingual Spray http://www.drugs.com/subsys.html Date of Approval: January 4, 2012 Treatment for: Pain Subsys Drug Information: http://www.drugs.com/subsys.html Press Release: http://www.drugs.com/newdrugs/insys-therapeutics-announces-fda-approval-subsys-fentanyl-sublingual-3013.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Velcade (bortezomib) for Injection http://www.drugs.com/velcade.html New Dosage Regimen: January 23, 2012 Now Approved: Subcutaneous Administration Velcade Drug Information: http://www.drugs.com/velcade.html Press Release: http://www.drugs.com/newdrugs/fda-approves-subcutaneous-administration-velcade-all-approved-indications-3068.html Prevnar 13 (pneumococcal 13-valent conjugate vaccine) http://www.drugs.com/prevnar-13.html Patient Population Altered: December 30, 2011 Now Approved for: People Aged 50 and Older Prevnar 13 Drug Information: http://www.drugs.com/prevnar-13.html Press Release: http://www.drugs.com/newdrugs/fda-expands-prevnar-13-vaccine-ages-50-older-3011.html Viread (tenofovir disoproxil fumarate) Tablets http://www.drugs.com/viread.html Patient Population Altered: January 19, 2012 Now Approved for: Children Aged 2-12 Years with HIV Viread Drug Information: http://www.drugs.com/viread.html Press Release: http://www.drugs.com/newdrugs/u-s-food-administration-approves-new-formulations-viread-children-living-hiv-3044.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.Methylphenidate Hydrochloride Extended-Release Capsules (LA) 20 mg, 30 mg and 40 mg Approved: December 1, 2011 - Actavis South Atlantic LLC Generic for: Ritalin LA CapsulesFelbamate Oral Suspension 600 mg/5 mL Approved: December 16, 2011 - Amneal Pharmaceuticals Generic for: Felbatol Oral SuspensionFenofibrate Tablets 48 mg and 145 mg Approved: December 23, 2011 - Lupin Limited Generic for: Tricor TabletsTramadol Hydrochloride Extended-Release Tablets 100 mg, 200 mg and 300 mg (Once Daily) Approved: December 30, 2011 - Sun Pharma Global FZE Generic for: Ryzolt Tablets Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Researchers Spot Potential Bile Duct Cancer Drug Targets http://www.drugs.com/news/researchers-spot-potential-bile-duct-cancer-targets-36101.html Study Finds No Link Between HPV Vaccine and Autoimmune Disorders http://www.drugs.com/news/study-finds-no-link-between-hpv-vaccine-autoimmune-disorders-36088.html Women Can Take Steps to Prevent Cervical Cancer http://www.drugs.com/news/women-can-steps-prevent-cervical-cancer-36072.html Drug May Slow Early Prostate Cancer: Study http://www.drugs.com/news/may-slow-early-prostate-cancer-study-36045.html Melanoma Drug's Link to Other Skin Cancers Identified http://www.drugs.com/news/melanoma-s-link-other-skin-cancers-identified-35969.html New Drug Combo for Hepatitis C Shows Promise http://www.drugs.com/news/new-combo-hepatitis-c-shows-promise-35968.html Drug Duo May Help Fight Aggressive Form of Breast Cancer http://www.drugs.com/news/duo-may-help-fight-aggressive-breast-cancer-35928.html 'Bath-Salts' Injection Leads to Flesh-Eating Disease http://www.drugs.com/news/bath-salts-leads-flesh-eating-35901.html Herbal Medicines for Arthritis Not Backed by Evidence http://www.drugs.com/news/herbal-medicines-arthritis-not-backed-evidence-35848.html Study Challenges Potassium Guidelines for Heart Attack Patients http://www.drugs.com/news/study-challenges-potassium-guidelines-heart-attack-patients-35819.html Too Much Vitamin D Could Be Harmful to Heart http://www.drugs.com/news/much-vitamin-d-could-harmful-heart-35816.html New Blood Thinner Linked To Higher Heart Attack Risk http://www.drugs.com/news/new-blood-thinner-linked-higher-heart-attack-risk-35796.html Low-Dose Aspirin to Prevent First Heart Attack or Stroke? Not So Fast http://www.drugs.com/news/low-aspirin-prevent-first-heart-attack-stroke-not-so-fast-35795.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Recall: Treanda (bendamustine HCL) - Particulate Matter in Vial http://www.drugs.com/fda/treanda-bendamustine-hcl-recall-particulate-matter-vial-13072.html Drug Safety Communication: Tysabri (natalizumab) - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) http://www.drugs.com/fda/tysabri-natalizumab-safety-communication-new-risk-factor-progressive-multifocal-leukoencephalopathy-13069.html Recall: Perfect Image Solutions Topical Hair Regrowth Products http://www.drugs.com/fda/perfect-image-solutions-topical-hair-regrowth-products-recall-unapproved-risk-health-hazards-13070.html Recall: Vagifresh Ball, Vagifresh Gel, Female One - Undeclared Drug Ingredient, Bacterial Contamination http://www.drugs.com/fda/vagifresh-ball-vagifresh-gel-female-one-recall-undeclared-ingredient-bacterial-contamination-13071.html Drug Safety Communication: Adcetris (brentuximab vedotin) - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity http://www.drugs.com/fda/adcetris-brentuximab-vedotin-safety-communication-progressive-multifocal-leukoencephalopathy-13068.html Recall: Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection - Glass Particles http://www.drugs.com/fda/bedford-laboratories-polymyxin-b-usp-vecuronium-bromide-recall-glass-particles-13065.html Drug Safety Communication: CardioGen-82 PET Scan - Increased Radiation Exposure http://www.drugs.com/fda/cardiogen-82-pet-scan-safety-communication-increased-radiation-exposure-13066.html Public Health Advisory: Endo Pharmaceuticals Opiate Products by Novartis Consumer Health - Potential Safety Risk http://www.drugs.com/fda/endo-pharmaceuticals-opiate-products-novartis-consumer-health-public-health-advisory-potential-13063.html Recall: Novartis Consumer Health Over-The-Counter Products - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps http://www.drugs.com/fda/novartis-consumer-health-over-counter-products-recall-potential-presence-foreign-chipped-broken-13064.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/ 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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