Drugs.com Newsletter Vol 81 - May 2011 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- Lists of Prescription Meds' Side Effects Keep Growing: Study May 2011 - Lists of the side effects for prescription medications on drug labels, packaging and advertisements have mushroomed up to an average of 70 per medication, a new study reports Read more: http://www.drugs.com/news/lists-meds-keep-growing-study-31612.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Dificid (fidaxomicin) http://www.drugs.com/dificid.html Date of Approval: May 27, 2011 Treatment for: Clostridial Infection Dificid Drug Information: http://www.drugs.com/dificid.html Press Release: http://www.drugs.com/newdrugs/fda-approves-dificid-clostridium-difficile-infection-2689.html Incivek (telaprevir) Tablets http://www.drugs.com/incivek.html Date of Approval: May 23, 2011 Treatment for: Chronic Hepatitis C Incivek Drug Information: http://www.drugs.com/incivek.html Press Release: http://www.drugs.com/newdrugs/fda-approves-incivek-telaprevir-hepatitis-c-2681.html Edurant (rilpivirine) Tablets http://www.drugs.com/edurant.html Date of Approval: May 20, 2011 Treatment for: HIV Infection Edurant Drug Information: http://www.drugs.com/edurant.html Press Release: http://www.drugs.com/newdrugs/fda-approves-new-hiv-edurant-rilpivirine-2677.html Victrelis (boceprevir) http://www.drugs.com/victrelis.html Date of Approval: May 13, 2011 Treatment for: Chronic Hepatitis C Victrelis Drug Information: http://www.drugs.com/victrelis.html Press Release: http://www.drugs.com/newdrugs/fda-approves-merck-s-victrelis-boceprevir-first-class-oral-hepatitis-c-virus-hcv-protease-inhibitor-2651.html Tradjenta (linagliptin) Tablets http://www.drugs.com/tradjenta.html Date of Approval: May 2, 2011 Treatment for: Diabetes Mellitus Type II Tradjenta Drug Information: http://www.drugs.com/tradjenta.html Press Release: http://www.drugs.com/newdrugs/fda-approves-tradjenta-type-2-diabetes-2643.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Fluzone (influenza virus vaccine, inactivated) Suspension for Intramuscular Injection http://www.drugs.com/mtm/fluzone-injectable.html New Formulation Approved: May 10, 2011 Now Approved: Fluzone Intradermal Fluzone Drug Information: http://www.drugs.com/mtm/fluzone-injectable.html Press Release: http://www.drugs.com/newdrugs/fda-licenses-fluzone-intradermal-sanofi-pasteur-s-new-influenza-vaccine-delivered-intradermal-2650.html Afinitor (everolimus) Tablets http://www.drugs.com/afinitor.html New Indication Approved: May 6, 2011 Now Approved for: Pancreatic Neuroendocrine Tumors Afinitor Drug Information: http://www.drugs.com/afinitor.html Press Release: http://www.drugs.com/newdrugs/novartis-gains-fda-approval-afinitor-first-new-nearly-three-decades-patients-advanced-pancreatic-net-2648.html Sutent (sunitinib malate) Capsules http://www.drugs.com/cdi/sutent.html New Indication Approved: May 20, 2011 Now Approved for: Pancreatic Neuroendocrine Tumors Sutent Drug Information: http://www.drugs.com/cdi/sutent.html Press Release: http://www.drugs.com/newdrugs/fda-approves-sutent-rare-type-pancreatic-cancer-2678.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.Exemestane Tablets 25 mg Approved: April 1, 2011 - Roxane Laboratories, Inc. Generic for: Aromasin TabletsParoxetine Hydrochloride Extended-Release Tablets 37.5 mg (base) Approved: April 14, 2011 - Mylan Pharmaceuticals, Inc. Generic for: Paxil CR TabletsCyclobenzaprine Hydrochloride Extended-Release Capsules 15 mg and 30 mg Approved: April 18, 2011 - Mylan Pharmaceuticals, Inc. Generic for: Amrix Extended-Release CapsulesDesloratadine and Pseudoephedrine Sulfate Extended-Release Tablets 5 mg/240 mg (24-Hour Formulation) Approved: April 26, 2011 - Dr. Reddy's Laboratories Limited Generic for: Clarinex-D 24-Hour Extended-Release Tablets Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Daily Four-Drug Combo Pill Halves Heart Disease Risk: Study http://www.drugs.com/news/daily-four-combo-pill-halves-heart-risk-study-31596.html With Calcium, More May Not Be Better http://www.drugs.com/news/calcium-more-may-not-better-31575.html Too Many Kids Getting Antibiotics for Asthma http://www.drugs.com/news/many-kids-getting-antibiotics-asthma-31552.html Certain COPD Meds Linked to Urinary Troubles in Men http://www.drugs.com/news/certain-copd-meds-linked-urinary-troubles-men-31541.html Side Effects May Sway Drug Choices for Tough-to-Manage Diabetes http://www.drugs.com/news/may-sway-choices-tough-manage-diabetes-31494.html FDA to Pull Diabetes Drug Avandia From Pharmacy Shelves http://www.drugs.com/news/fda-pull-diabetes-avandia-pharmacy-shelves-31480.html FDA Advisers Urge Infant Doses for Kids' OTC Fever Relievers http://www.drugs.com/news/fda-advisers-urge-infant-doses-kids-otc-fever-relievers-31460.html Newer Epilepsy Meds Less Likely to Cause Birth Defects: Study http://www.drugs.com/news/newer-epilepsy-meds-less-likely-cause-birth-defects-study-31441.html ADHD Drug Shortage Has Patients, Parents Scrambling http://www.drugs.com/news/adhd-shortage-has-patients-parents-scrambling-31321.html Asthma Pills Work as Well as Inhaled Steroids: Study http://www.drugs.com/news/asthma-pills-work-well-inhaled-steroids-study-31178.html Many Consumers Don't Know What's in Over-the-Counter Painkillers: Study http://www.drugs.com/news/many-consumers-don-t-know-s-over-counter-painkillers-study-31123.html Study Questions Giving Babies Botanical Supplements, Teas http://www.drugs.com/news/study-questions-giving-babies-botanical-supplements-teas-31099.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Slim Xtreme Herbal Slimming Capsule: Undeclared Drug Ingredient http://www.drugs.com/fda/slim-xtreme-herbal-slimming-capsule-undeclared-ingredient-12966.html Recall: Pentrexyl Forte Natural - Misleading Packaging http://www.drugs.com/fda/pentrexyl-forte-natural-recall-misleading-packaging-12965.html Public Health Notification: SimplyThick - Risk of Life-Threatening Bowel Condition http://www.drugs.com/fda/simplythick-public-health-notification-risk-threatening-bowel-condition-12963.html Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events http://www.drugs.com/fda/avandia-rosiglitazone-rems-risk-cardiovascular-events-12962.html Recall: ExtenZe Tablets http://www.drugs.com/fda/extenze-recall-12961.html Recall: Multi-Mex Distributor Inc. Dietary Supplements - Product Packaging Mimics OTC Antibiotics http://www.drugs.com/fda/multi-mex-distributor-inc-dietary-supplements-recall-product-packaging-mimics-otc-antibiotics-12958.html Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems http://www.drugs.com/fda/needleless-pre-filled-glass-syringes-stakeholder-advisory-compatibility-problems-needleless-12955.html American Regent Injectable Products: Recall - Visible Particulates in Products http://www.drugs.com/fda/american-regent-injectable-products-recall-visible-particulates-products-12956.html Recall: Coumadin (warfarin sodium) Crystalline 5 mg Tablets - Tablets May Have Higher than Expected Potency http://www.drugs.com/fda/coumadin-warfarin-sodium-crystalline-5-mg-recall-may-have-higher-than-expected-potency-12953.html Recall: Regenerect - Undeclared Drug Ingredient http://www.drugs.com/fda/regenerect-recall-undeclared-ingredient-12952.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. We are dedicated to providing consumers and health professionals with objective information about prescription-medication discoveries and side effects. This information is not intended to be medical advice. You should contact your physician before making any changes to your health care. Drugs.com is not responsible for content provided by third-party web sites. Your Feedback We sent this e-mail to %PERS_EMAIL% at your request. We always appreciate feedback so if you wish to give us your comments/ praise/ rebuke please Contact Us here: http://www.drugs.com/support/contact.html Thanks so much for your continued support! The Editorial Team Drugs.com Your Privacy - Any personal information you provide to us will only be used to notify you of offers, information and activities. We'll hold the information about you securely and will not disclose it except for this purpose, or when required by law. Copyright © 2011 Drugs.com. All Rights Reserved.