Drugs.com Newsletter Vol 94 - June 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 News Round Up - June 2012 June 2012 - Belviq (lorcaserin) Approved For Obesity Treatment In a long awaited decision, the FDA has approved the weight-loss drug Belviq (lorcaserin) Read more: http://www.drugs.com/news/monthly-news-round-up-june-2012-39037.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Myrbetriq (mirabegron) Extended Release Tablets http://www.drugs.com/myrbetriq.html Date of Approval: June 28, 2012 Treatment for: Overactive Bladder Myrbetriq Drug Information: http://www.drugs.com/myrbetriq.html Press Release: http://www.drugs.com/newdrugs/fda-approves-myrbetriq-overactive-bladder-3344.html Belviq (lorcaserin) Tablets http://www.drugs.com/belviq.html Date of Approval: June 27, 2012 Treatment for: Obesity Belviq Drug Information: http://www.drugs.com/belviq.html Press Release: http://www.drugs.com/newdrugs/fda-approves-belviq-some-overweight-obese-adults-3341.html MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) http://www.drugs.com/menhibrix.html Date of Approval: June 14, 2012 Treatment for: Haemophilus influenzae Prophylaxis, Meningococcal Meningitis Prophylaxis MenHibrix Drug Information: http://www.drugs.com/menhibrix.html Press Release: http://www.drugs.com/newdrugs/gsk-receives-fda-approval-menhibrix-3336.html Perjeta (pertuzumab) Injection http://www.drugs.com/perjeta.html Date of Approval: June 8, 2012 Treatment for: Breast Cancer Perjeta Drug Information: http://www.drugs.com/perjeta.html Press Release: http://www.drugs.com/newdrugs/fda-approves-perjeta-pertuzumab-her2-positive-metastatic-breast-cancer-3313.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Horizant (gabapentin enacarbil) Extended Release Tablets http://www.drugs.com/horizant.html New Indication Approved: June 6, 2012 Now Approved for: Postherpetic Neuralgia Horizant Drug Information: http://www.drugs.com/horizant.html Press Release: http://www.drugs.com/newdrugs/gsk-xenoport-receive-fda-approval-horizant-postherpetic-neuralgia-3312.html Gammagard Liquid (immune globulin infusion (human)) Solution http://www.drugs.com/gammagard.html New Indication Approved: June 25, 2012 Now Approved for: Multifocal Motor Neuropathy Gammagard Liquid Drug Information: http://www.drugs.com/gammagard.html Press Release: http://www.drugs.com/newdrugs/baxter-announces-fda-approval-gammagard-liquid-multifocal-motor-neuropathy-3339.html Lyrica (pregabalin) Capsules http://www.drugs.com/lyrica.html New Indication Approved: June 20, 2012 Now Approved for: Neuropathic Pain Associated with Spinal Cord Injury Lyrica Drug Information: http://www.drugs.com/lyrica.html Press Release: http://www.drugs.com/newdrugs/fda-approves-lyrica-management-neuropathic-pain-associated-spinal-cord-injury-based-priority-review-3337.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.Armodafinil Tablets 50 mg, 150 mg and 250 mg Approved: June 1, 2012 - Mylan Pharmaceuticals, Inc. Generic for: NuvigilAdapalene Gel 0.3% Approved: June 14, 2012 - Tolmar, Inc. Generic for: Differin Gel 0.3%Abacavir Sulfate Tablets 300 mg (base) Approved: June 18, 2012 - Mylan Pharmaceuticals Inc. Generic for: ZiagenOlanzapine and Fluoxetine Hydrochloride Capsules 25 mg (base)/6 mg (base), 25 mg (base)/12 mg (base), 50 mg (base)/6 mg (base) and 50 mg (base)/12 mg (base) Approved: June 19, 2012 - Teva Pharmaceuticals USA Inc. Generic for: SymbyaxMetformin Hydrochloride and Pioglitazone Hydrochloride Tablets 500 mg/15 mg (base) and 850 mg/15 mg (base) Approved: June 26, 2012 - Mylan Pharmaceuticals, Inc. Generic for: Actoplus MetLinezolid Injection 200 mg/100 mL Approved: June 27, 2012 - Teva Pharmaceuticals USA Inc. Generic for: Zyvox InjectionCidofovir Injection 75 mg (base)/mL Approved: June 27, 2012 - Mylan Pharmaceuticals, Inc. Generic for: Vistide Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Metformin Outperforms Common Class of Diabetes Drugs in Study http://www.drugs.com/news/metformin-outperforms-common-class-diabetes-study-38910.html Effects of High Blood Pressure Drug May Mimic Celiac Disease http://www.drugs.com/news/blood-pressure-may-mimic-celiac-38900.html Genes May Influence Reactions to Painkillers http://www.drugs.com/news/genes-may-influence-reactions-painkillers-38862.html New Therapies Show Some Promise Against Pancreatic Cancer http://www.drugs.com/news/new-therapies-show-some-promise-against-pancreatic-cancer-38840.html Arthritis Treatment Linked to Liver Problems in Study http://www.drugs.com/news/arthritis-linked-liver-problems-study-38824.html Birth Control That Uses Combined Hormones Raises Heart Risk: Study http://www.drugs.com/news/birth-control-uses-combined-hormones-raises-heart-risk-study-38733.html Older Women Should Not Take Calcium, Vitamin D: Task Force http://www.drugs.com/news/older-women-should-not-calcium-vitamin-d-task-force-38705.html Statins May Leave Patients With Less Energy: Study http://www.drugs.com/news/statins-may-leave-patients-less-energy-study-38671.html Diabetes Drugs Avandia, Actos Linked to Vision Woes http://www.drugs.com/news/diabetes-avandia-actos-linked-vision-woes-38672.html New Medicine Might Fight Drug-Resistant TB, Study Says http://www.drugs.com/news/new-medicine-might-fight-resistant-tb-study-says-38591.html Antibiotic-Resistant Gonorrhea Spreading: WHO http://www.drugs.com/news/antibiotic-resistant-gonorrhea-spreading-38583.html Daily Low-Dose Aspirin Risks Seem to Outweigh Gains for Many: Study http://www.drugs.com/news/daily-low-aspirin-risks-seem-outweigh-gains-many-study-38571.html Ginseng Capsules Seem to Ease Cancer-Related Fatigue http://www.drugs.com/news/ginseng-capsules-seem-ease-cancer-related-fatigue-38544.html New 'Personalized' Drugs Show Promise Against Melanoma, Lung Cancer http://www.drugs.com/news/new-personalized-show-promise-against-melanoma-lung-cancer-38536.html Antidepressant Cymbalta Might Ease Chemo-Linked Pain http://www.drugs.com/news/antidepressant-cymbalta-might-ease-chemo-linked-pain-38535.html Many Americans Taking Too Much Acetaminophen http://www.drugs.com/news/many-americans-much-acetaminophen-38516.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation http://www.drugs.com/fda/ondansetron-zofran-iv-safety-communication-qt-prolongation-13140.html Vecuronium Bromide For Injection Preservative Free (Bedford Laboratories): Recall - Particulate Matter http://www.drugs.com/fda/vecuronium-bromide-preservative-free-bedford-laboratories-recall-particulate-matter-13141.html Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors http://www.drugs.com/fda/dialysate-concentrates-hemodialysis-safety-communication-alkali-dosing-errors-13138.html Label Change: Cefepime - Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment http://www.drugs.com/fda/cefepime-label-change-risk-seizure-patients-not-receiving-adjustments-kidney-impairment-13137.html Recall: Digestive 3 in 1 Health Liquid Dietary Supplement - Potential for Contamination With Salmonella http://www.drugs.com/fda/digestive-3-1-health-liquid-dietary-supplement-recall-potential-contamination-salmonella-13135.html Recall: Introvale (levonorgestrel and ethinyl estradiol) Tablets - Packaging Flaw http://www.drugs.com/fda/introvale-levonorgestrel-ethinyl-estradiol-recall-packaging-flaw-13134.html Recall: Reumofan Plus - Undeclared Drug Ingredient http://www.drugs.com/fda/reumofan-plus-recall-undeclared-ingredient-13132.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 - 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