Drugs.com Newsletter Vol 75 - November 2010 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- Confusing Labeling Found on Many Nonprescription Kids' Meds November 2010 - The admonishment to parents to carefully follow the directions on the labels of over-the-counter kids' medicines may be futile, new research suggests Read more: http://www.drugs.com/news/confusing-labeling-found-many-nonprescription-kids-meds-28104.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Axiron (testosterone) Topical Solution http://www.drugs.com/axiron.html Date of Approval: November 23, 2010 Treatment for: Hypogonadism -- Male Axiron Drug Information: http://www.drugs.com/axiron.html Press Release: http://www.drugs.com/newdrugs/lilly-acrux-receive-fda-approval-axiron-testosterone-topical-solution-ciii-2456.html Gablofen (baclofen) Injection http://www.drugs.com/gablofen.html Date of Approval: November 19, 2010 Treatment for: Cerebral Spasticity, Chronic Spasticity Gablofen Drug Information: http://www.drugs.com/gablofen.html Press Release: http://www.drugs.com/newdrugs/fda-approves-movement-disorder-cns-therapeutics-gablofen-baclofen-severe-spasticity-2435.html Xgeva (denosumab) Injection http://www.drugs.com/xgeva.html Date of Approval: November 18, 2010 Treatment for: Osteolytic Bone Metastases of Solid Tumors Xgeva Drug Information: http://www.drugs.com/xgeva.html Press Release: http://www.drugs.com/newdrugs/fda-approves-amgen-s-xgeva-denosumab-prevention-skeletal-related-events-patients-bone-metastases-2411.html Halaven (eribulin mesylate) Injection http://www.drugs.com/halaven.html Date of Approval: November 15, 2010 Treatment for: Breast Cancer Halaven Drug Information: http://www.drugs.com/halaven.html Press Release: http://www.drugs.com/newdrugs/fda-approves-halaven-late-stage-breast-cancer-2406.html Egrifta (tesamorelin) Injection http://www.drugs.com/egrifta.html Date of Approval: November 10, 2010 Treatment for: Reduction of Excess Abdominal Fat in HIV-Infected Patients with Lipodystrophy Egrifta Drug Information: http://www.drugs.com/egrifta.html Press Release: http://www.drugs.com/newdrugs/fda-approves-egrifta-tesamorelin-first-only-reduction-excess-abdominal-fat-hiv-infected-patients-2401.html Kombiglyze XR (saxagliptin and metformin) Extended-Release Tablets http://www.drugs.com/kombiglyze-xr.html Date of Approval: November 5, 2010 Treatment for: Diabetes Mellitus Type II Kombiglyze XR Drug Information: http://www.drugs.com/kombiglyze-xr.html Press Release: http://www.drugs.com/newdrugs/kombiglyze-xr-saxagliptin-metformin-hcl-extended-release-approved-u-s-type-2-diabetes-mellitus-2399.html Ofirmev (acetaminophen) Intravenous Injection http://www.drugs.com/ofirmev.html Date of Approval: November 2, 2010 Treatment for: Fever, Pain Ofirmev Drug Information: http://www.drugs.com/ofirmev.html Press Release: http://www.drugs.com/newdrugs/cadence-pharmaceuticals-announces-fda-approval-ofirmev-acetaminophen-management-pain-fever-2397.html Nuedexta (dextromethorphan and quinidine) http://www.drugs.com/nuedexta.html Date of Approval: October 29, 2010 Treatment for: Pseudobulbar Affect Nuedexta Drug Information: http://www.drugs.com/nuedexta.html Press Release: http://www.drugs.com/newdrugs/avanir-pharmaceuticals-announces-fda-approval-nuedexta-2392.html Teflaro (ceftaroline fosamil) Injection http://www.drugs.com/teflaro.html Date of Approval: October 29, 2010 Treatment for: Pneumonia, Skin and Structure Infection Teflaro Drug Information: http://www.drugs.com/teflaro.html Press Release: http://www.drugs.com/newdrugs/fda-approves-teflaro-bacterial-infections-2391.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Nexterone (amiodarone HCl) Injection http://www.drugs.com/nexterone.html New Formulation Approved: November 16, 2010 Now Approved: Nexterone Ready-to-Use Premixed Injection Nexterone Drug Information: http://www.drugs.com/nexterone.html Press Release: http://www.drugs.com/newdrugs/prism-pharmaceuticals-receives-fda-approval-ready-nexterone-amiodarone-hcl-premixed-2410.html Cymbalta (duloxetine) Delayed-Release Capsules http://www.drugs.com/cymbalta.html New Indication Approved: November 4, 2010 Now Approved for: Chronic Musculoskeletal Pain Cymbalta Drug Information: http://www.drugs.com/cymbalta.html Press Release: http://www.drugs.com/newdrugs/fda-clears-cymbalta-chronic-musculoskeletal-pain-2398.html Vyvanse (lisdexamfetamine dimesylate) Capsules http://www.drugs.com/vyvanse.html Patient Population Altered: November 10, 2010 Now Approved for: ADHD in Adolescents Vyvanse Drug Information: http://www.drugs.com/vyvanse.html Press Release: http://www.drugs.com/newdrugs/fda-approves-vyvanse-lisdexamfetamine-dimesylate-capsules-cii-adhd-adolescents-2404.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.Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL Approved: October 1, 2010 - Tris Pharma, Inc. Generic for: Tussionex Pennkinetic Extended-Release Oral SuspensionZolpidem Tartrate Extended-Release Tablets USP 6.25 mg Approved: October 13, 2010 - Actavis South Atlantic LLC Generic for: Ambien CRLansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg and 30 mg Approved: October 15, 2010 - Teva Pharmaceuticals USA Generic for: Prevacid SoluTab Delayed-Release Orally Disintegrating TabletsPropafenone Hydrochloride Extended-Release Capsules 225 mg, 325 mg and 425 mg Approved: October 18, 2010 - Par Pharmaceutical, Inc. Generic for: Rythmol SR Capsules Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Breast Cancer Rates Lower With Less Hormone Therapy: Study http://www.drugs.com/news/breast-cancer-rates-lower-less-hormone-therapy-study-28106.html Prescriptions for Stimulants, Painkillers Soaring Among Youth http://www.drugs.com/news/prescriptions-stimulants-painkillers-soaring-among-youth-28086.html Celebrex Shows Potential in Preventing Some Skin Cancers: Study http://www.drugs.com/news/celebrex-shows-potential-preventing-some-skin-cancers-study-28080.html Smarten Up About Antibiotics, CDC Urges http://www.drugs.com/news/smarten-up-antibiotics-cdc-urges-27923.html Warfarin Patients Often Unaware of Risks from Herbs, Supplement Use http://www.drugs.com/news/warfarin-patients-often-unaware-risks-herbs-supplement-27840.html Severe Acne May Up Suicide Risk: Study http://www.drugs.com/news/severe-acne-may-up-suicide-risk-study-27783.html Painkillers in Pregnancy May Harm Son's Fertility, Study Suggests http://www.drugs.com/news/painkillers-pregnancy-may-harm-son-s-fertility-study-suggests-27781.html Long-Term Statin Use Won't Raise Cancer Risk: Study http://www.drugs.com/news/long-term-statin-won-t-raise-cancer-risk-study-27741.html Few Young Women Getting Cervical Cancer Vaccine http://www.drugs.com/news/few-young-women-getting-cervical-cancer-vaccine-27735.html New Malaria Drug Proves Effective in Study of African Children http://www.drugs.com/news/new-malaria-proves-effective-study-african-children-27681.html Fish Oil Supplements May Not Slow Alzheimer's http://www.drugs.com/news/fish-oil-supplements-may-not-slow-alzheimer-s-27603.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Propoxyphene: Withdrawal - Risk of Cardiac Toxicity http://www.drugs.com/fda/propoxyphene-risk-cardiac-toxicity-12855.html Warning: Vigor-25 - Undeclared Drug Ingredient http://www.drugs.com/fda/vigor-25-undeclared-ingredient-sold-natural-dietary-supplement-12856.html Recall: Duro Extend Capsules for Men - Undeclared Drug Ingredient http://www.drugs.com/fda/duro-extend-capsules-men-recall-undeclared-ingredient-12848.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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