Drugs.com Newsletter Vol 57 - May 2009 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- Most Americans Would Consider Splitting Pills to Save Money If Medicine Remains Safe and Effective, Survey Shows May 2009 - More than half of Americans said they would consider splitting their prescription pills to save money if their doctor said it would not be detrimental to their health, according to results of a national poll conducted by Opinion Research Corp Read more: http://www.drugs.com/news/most-americans-would-consider-splitting-pills-to-save-money-if-medicine-remains-safe-and-effective-survey-shows-17821.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Adcirca (tadalafil) Tablets http://www.drugs.com/adcirca.html Date of Approval: May 22, 2009 Treatment for: Pulmonary Hypertension Adcirca Drug Information: http://www.drugs.com/adcirca.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-adcirca-tadalafil-tablets-for-the-treatment-of-pulmonary-arterial-hypertension-1366.html Samsca (tolvaptan) Tablets http://www.drugs.com/samsca.html Date of Approval: May 19, 2009 Treatment for: Hyponatremia Samsca Drug Information: http://www.drugs.com/samsca.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-samsca-tolvaptan-the-first-and-only-oral-vasopressin-antagonist-to-treat-patients-with-clinically-significant-hypervolemic-and-euvolemic-hyponatremia-1365.html Fanapt (iloperidone) Tablets http://www.drugs.com/fanapt.html Date of Approval: May 6, 2009 Treatment for: Schizophrenia Fanapt Drug Information: http://www.drugs.com/fanapt.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-fanapt-to-treat-schizophrenia-1345.html Cycloset (bromocriptine mesylate) Tablets http://www.drugs.com/cycloset.html Date of Approval: May 5, 2009 Treatment for: Diabetes Mellitus Type II Cycloset Drug Information: http://www.drugs.com/cycloset.htmlnPress Release: http://www.drugs.com/newdrugs/veroscience-announces-fda-approval-of-cycloset-for-treatment-of-type-2-diabetes-1344.html Creon (pancrelipase) Delayed-Release Capsules http://www.drugs.com/creon.html Date of Approval: April 30, 2009 Treatment for: Pancreatic Exocrine Dysfunction Creon Drug Information: http://www.drugs.com/creon.htmlnPress Release: http://www.drugs.com/newdrugs/creon-pancrelipase-delayed-release-capsules-first-and-only-pancreatic-enzyme-product-to-receive-fda-approval-under-new-guidelines-1339.html Cetraxal (ciprofloxacin otic) Solution http://www.drugs.com/cetraxal.html Date of Approval: May 1, 2009 Treatment for: Otitis Externa Cetraxal Drug Information: http://www.drugs.com/cetraxal.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-cetraxal-otic-solution-1348.html Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets http://www.drugs.com/exforge-hct.html Date of Approval: April 30, 2009 Treatment for: Hypertension Exforge HCT Drug Information: http://www.drugs.com/exforge-hct.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-exforge-hct-the-only-high-blood-pressure-treatment-to-combine-three-medications-in-a-single-pill-1337.html Dysport (abobotulinumtoxinA) Date of Approval: April 30, 2009 Treatment for: Cervical Dystonia, Glabellar Lines Press Release: http://www.drugs.com/newdrugs/fda-approves-dysport-for-therapeutic-and-aesthetic-uses-1336.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Prevacid (lansoprazole) http://www.drugs.com/prevacid.html New Dosage Form Approved: May 13, 2009 Now Approved: Prevacid 24HR (OTC) Prevacid Drug Information: http://www.drugs.com/prevacid.htmlnPress Release: http://www.drugs.com/newdrugs/novartis-receives-approval-from-fda-to-market-prevacid-24hr-as-first-and-only-otc-proton-pump-inhibitor-in-original-prescription-formulation-1360.html ACTOplus met (pioglitazone and metformin) Tablets http://www.drugs.com/actoplus_met.html New Dosage Form Approved: May 12, 2009 Now Approved: ACTOplus met XR ACTOplus met Drug Information: http://www.drugs.com/actoplus_met.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-actoplus-met-xr-pioglitazone-hcl-and-metformin-hcl-extended-release-tablets-for-the-treatment-of-type-2-diabetes-1352.html Lamictal (lamotrigine) http://www.drugs.com/lamictal.html New Dosage Form Approved: May 8, 2009 Now Approved: Lamictal ODT Orally Disintegrating Tablets Lamictal Drug Information: http://www.drugs.com/lamictal.htmlnPress Release: http://www.drugs.com/newdrugs/fda-approves-lamictal-odt-orally-disintegrating-tablets-1350.html Risperdal (risperidone) http://www.drugs.com/risperdal.html New Indication Approved: May 15, 2009 Now Approved: Risperdal Consta for Bipolar I Disorder Risperdal Drug Information: http://www.drugs.com/risperdal.htmlnPress Release: http://www.drugs.com/newdrugs/fda-grants-approval-for-use-of-risperdal-consta-as-both-a-monotherapy-and-adjunctive-therapy-in-the-maintenance-treatment-of-bipolar-i-disorder-1354.html Cimzia (certolizumab pegol) Injection http://www.drugs.com/cimzia.html New Indication Approved: May 13, 2009 Now Approved for: Rheumatoid Arthritis Cimzia Drug Information: http://www.drugs.com/cimzia.htmlnPress Release: http://www.drugs.com/newdrugs/ucb-s-cimzia-certolizumab-pegol-approved-by-the-u-s-fda-for-adult-patients-suffering-from-moderate-to-severe-rheumatoid-arthritis-1353.html Azor (amlodipine and olmesartan) Tablets http://www.drugs.com/azor.html New Indication Approved: May 11, 2009 Now Approved for: First-Line Treatment for High Blood Pressure Azor Drug Information: http://www.drugs.com/azor.htmlnPress Release: http://www.drugs.com/newdrugs/azor-receives-fda-approval-as-first-line-treatment-for-high-blood-pressure-1351.html Avastin (bevacizumab) Injection http://www.drugs.com/avastin.html New Indication Approved: May 5, 2009 Now Approved for: Glioblastoma Avastin Drug Information: http://www.drugs.com/avastin.htmlnPress Release: http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-of-avastin-for-brain-cancer-glioblastoma-that-has-progressed-following-prior-therapy-1342.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. Risperidone Orally Disintegrating Tablets 0.25 mg, 0.5 mg, 2 mg, 3 mg and 4 mg Approved: April 30, 2009 Kali Laboratories, Inc. Generic for: Risperdal-M Tab (Orally Disintegrating Tablet) Mivacurium Chloride Injection 2 mg (base)/mL; packaged in 10 mg (base)/5 mL and 20 mg (base)/10 mL single-dose vials Approved: April 30, 2009 Ebewe Parenta Pharmaceuticals, Inc. Generic for: Mivacron Injection Azelastine Hydrochloride Nasal Solution (Nasal Spray) 0.1% [125 mcg (base)/spray] Approved: April 30, 2009 Apotex Inc. Generic for: Astelin Nasal Spray Lorazepam Oral Concentrate USP 2 mg/mL Approved: April 28, 2009 Paddock Laboratories, Inc. Generic for: Lorazepam Intensol Topiramate Capsules (Sprinkle) 15 mg and 25 mg Approved: April 15, 2009 Cobalt Laboratories, Inc.; Barr Laboratories, Inc. Generic for: Topamax Sprinkle Capsules Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Parents Often Puzzled by Medicine Labels http://www.drugs.com/news/parents-often-puzzled-by-medicine-labels-17948.html Health Tip: Drugs That May Lead to Diarrhea http://www.drugs.com/news/health-tip-drugs-that-may-lead-to-diarrhea-17858.html Study Reiterates Eye Risks Linked to Flomax http://www.drugs.com/news/study-reiterates-eye-risks-linked-to-flomax-17850.html Pills Plus Psychotherapy Can Beat Insomnia http://www.drugs.com/news/pills-plus-psychotherapy-can-beat-insomnia-17852.html Multivitamins Might Prolong Life http://www.drugs.com/news/multivitamins-might-prolong-life-17806.html Chewable Aspirin More Readily Absorbed http://www.drugs.com/news/chewable-aspirin-more-readily-absorbed-17785.html Ginger Eases Nausea From Chemo http://www.drugs.com/news/ginger-eases-nausea-from-chemo-17765.html Before Conceiving, Take Folic Acid for One Full Year http://www.drugs.com/news/before-conceiving-take-folic-acid-for-one-full-year-17721.html Health Tip: Manage Medications Safely http://www.drugs.com/news/health-tip-manage-medications-safely-17657.html All Blood Pressure Drugs Lower Risk of Heart Attack and Stroke http://www.drugs.com/news/all-blood-pressure-drugs-lower-risk-of-heart-attack-and-stroke-17639.html Plavix, Heartburn Drugs May Be Risky Combination http://www.drugs.com/news/plavix-heartburn-drugs-may-be-risky-combination-17626.html Testosterone Injections Offer Hope for Male Contraceptive http://www.drugs.com/news/testosterone-injections-offer-hope-for-male-contraceptive-17583.html Smoking Packs a Tougher Wallop for Women http://www.drugs.com/news/smoking-packs-a-tougher-wallop-for-women-17564.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Additional Recall of Fun Express Water-based Face Paints for Children http://www.drugs.com/fda/fun-express-water-based-face-paints-for-children-12522.html Recall of Fun Express Water-based Face Paints for Children http://www.drugs.com/fda/fun-express-water-based-face-paints-for-children-12520.html Recall of Caraco brand Digoxin, USP 0.25 mg http://www.drugs.com/fda/digoxin-usp-0-25-mg-12519.html New Safety Information for Tarceva (erlotinib) http://www.drugs.com/fda/tarceva-erlotinib-12517.html Testosterone gel products (AndroGel and Testim) receive boxed warning http://www.drugs.com/fda/testosterone-gel-products-androgel-and-testim-12516.html FDA Approves Updated Labeling for Antiepileptic Drugs http://www.drugs.com/fda/antiepileptic-drugs-12333.html Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump Defect http://www.drugs.com/fda/disetronic-medical-systems-inc-accu-chek-spirit-insulin-pump-12515.html Hydroxycut Products http://www.drugs.com/fda/hydroxycut-products-12514.html Botox, Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) Warnings to be Strengthened http://www.drugs.com/fda/botox-and-botox-cosmetic-botulinum-toxin-type-a-and-myobloc-botulinum-toxin-type-b-12513.html Personal Care Non-Acetone Nail Polish Remover Recall http://www.drugs.com/fda/personal-care-non-acetone-nail-polish-remover-12512.html Libimax Recall http://www.drugs.com/fda/libimax-12511.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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