Drugs.com Newsletter Vol 80 - April 2011 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- Novel Hepatitis C Drug Holds Promise: FDA April 2011 - An experimental new drug that may treat hepatitis C more effectively than earlier medications will be reviewed Thursday by a panel of experts for the U.S Read more: http://www.drugs.com/news/novel-hepatitis-c-holds-promise-fda-31005.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Duexis (famotidine and ibuprofen) Tablets http://www.drugs.com/duexis.html Date of Approval: April 23, 2011 Treatment for: Osteoarthritis, Rheumatoid Arthritis, NSAID-Induced Ulcer Prophylaxis Duexis Drug Information: http://www.drugs.com/duexis.html Press Release: http://www.drugs.com/newdrugs/horizon-pharma-announces-fda-approval-duexis-ibuprofen-famotidine-2611.html Sylatron (peginterferon alfa-2b) http://www.drugs.com/sylatron.html Date of Approval: April 11, 2011 Treatment for: Malignant Melanoma Sylatron Drug Information: http://www.drugs.com/sylatron.html Press Release: http://www.drugs.com/newdrugs/fda-approves-merck-s-sylatron-peginterferon-alfa-2b-new-adjuvant-melanoma-microscopic-gross-nodal-2602.html Horizant (gabapentin enacarbil) http://www.drugs.com/horizant.html Date of Approval: April 6, 2011 Treatment for: Restless Legs Syndrome Horizant Drug Information: http://www.drugs.com/horizant.html Press Release: http://www.drugs.com/newdrugs/glaxosmithkline-xenoport-receive-fda-approval-horizant-2599.html vandetanib Tablets http://www.drugs.com/vandetanib.html Date of Approval: April 6, 2011 Treatment for: Thyroid Cancer vandetanib Drug Information: http://www.drugs.com/vandetanib.html Press Release: http://www.drugs.com/newdrugs/fda-approves-orphan-vandetanib-advanced-medullary-thyroid-cancer-2598.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Lamictal XR (lamotrigine) Extended Release Tablets http://www.drugs.com/mtm/lamictal-xr.html Labeling Revision Approved: April 25, 2011 Now Approved for: Conversion to Monotherapy for Treatment of Partial Seizures Lamictal XR Drug Information: http://www.drugs.com/mtm/lamictal-xr.html Press Release: http://www.drugs.com/newdrugs/fda-approves-lamictal-xr-lamotrigine-conversion-monotherapy-partial-seizures-appropriate-patients-2614.html Actemra (tocilizumab) Injection http://www.drugs.com/actemra.html New Indication Approved: April 15, 2011 Now Approved for: Systemic Juvenile Idiopathic Arthritis Actemra Drug Information: http://www.drugs.com/actemra.html Press Release: http://www.drugs.com/newdrugs/fda-approves-actemra-tocilizumab-systemic-juvenile-idiopathic-arthritis-sjia-2603.html Rituxan (rituximab) Injection for Intravenous Use http://www.drugs.com/rituxan.html New Indication Approved: April 19, 2011 Now Approved for: Wegener's Granulomatosis and Microscopic Polyangiitis Rituxan Drug Information: http://www.drugs.com/rituxan.html Press Release: http://www.drugs.com/newdrugs/fda-approves-rituxan-two-rare-disorders-2604.html Invega (paliperidone) http://www.drugs.com/invega.html Patient Population Altered: April 6, 2011 Now Approved for: Schizophrenia in Adolescents 12 to 17 years Invega Drug Information: http://www.drugs.com/invega.html Press Release: http://www.drugs.com/newdrugs/invega-approved-schizophrenia-adolescents-2600.html Menactra (meningococcal conjugate vaccine) http://www.drugs.com/menactra.html Patient Population Altered: April 22, 2011 Now Approved for: Prevention of Meningococcal Disease in Infants (9-23 months of age) Menactra Drug Information: http://www.drugs.com/menactra.html Press Release: http://www.drugs.com/newdrugs/fda-approves-menactra-prevent-meningococcal-infants-toddlers-2612.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.Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, 0.25 mg/0.025 mg (28-Day Regimen) Approved: March 9, 2011 - Watson Laboratories, Inc. Generic for: Ortho Tri-Cyclen Lo TabletsEpinastine Hydrochloride Ophthalmic Solution 0.05% Approved: March 14, 2011 - Cypress Pharmaceutical, Inc. Generic for: Elestat Ophthalmic Solution Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Many Kids With Epilepsy Don't Take Meds as Prescribed: Study http://www.drugs.com/news/many-kids-epilepsy-don-t-meds-study-30982.html Antidepressants Work Overall, But Some Symptoms May Persist http://www.drugs.com/news/antidepressants-work-overall-but-some-may-persist-30976.html Heart-Healthy Omega-3s Not Healthy for Prostate: Study http://www.drugs.com/news/heart-healthy-omega-3s-not-healthy-prostate-study-30961.html Common Painkillers May Blunt Antidepressants http://www.drugs.com/news/common-painkillers-may-blunt-antidepressants-30959.html Experts Offer New Guidance for Blood Pressure Control in Elderly http://www.drugs.com/news/experts-offer-new-guidance-blood-pressure-control-elderly-30953.html Scientists Discover How Peppermint Soothes Gastric Pain http://www.drugs.com/news/scientists-discover-peppermint-soothes-gastric-pain-30922.html Newer 'Pill' Linked to Higher Risk of Blood Clots http://www.drugs.com/news/newer-pill-linked-higher-risk-blood-clots-30905.html Women Taking Calcium Supplements May Risk Heart Health, Researchers Say http://www.drugs.com/news/women-calcium-supplements-may-risk-heart-health-researchers-say-30856.html Children With HIV at Higher Risk of Drug Resistance http://www.drugs.com/news/children-hiv-higher-risk-resistance-30855.html Most Parents Vaccinate Kids, Trust Docs' Advice on Shots http://www.drugs.com/news/most-parents-vaccinate-kids-trust-docs-advice-shots-30833.html Alcohol-Energy Drink Combo Riskier Than Booze Alone, Study Says http://www.drugs.com/news/alcohol-energy-drink-combo-riskier-than-booze-alone-study-says-30802.html New Treatment for Urinary Tract Infections Called Promising http://www.drugs.com/news/new-urinary-tract-infections-called-promising-30795.html Estrogen's Role in Breast Cancer Can Fluctuate http://www.drugs.com/news/estrogen-s-role-breast-cancer-can-fluctuate-30788.html Use of Dietary Supplements Keeps Climbing: CDC http://www.drugs.com/news/dietary-supplements-keeps-climbing-cdc-30743.html Fish Oil Promising Against Postpartum Depression in Small Trial http://www.drugs.com/news/fish-oil-promising-against-postpartum-depression-small-trial-30728.html Extended HPV Vaccine Schedule Seems Effective http://www.drugs.com/news/extended-hpv-vaccine-schedule-seems-effective-30720.html Drug Memantine Ineffective for Mild Alzheimer's, Study Finds http://www.drugs.com/news/memantine-ineffective-mild-alzheimer-s-study-finds-30708.html Acne Antibiotics Not Linked to Drug Resistance http://www.drugs.com/news/acne-antibiotics-not-linked-resistance-30705.html Brain Tumor Vaccine Shows Promise in Early Trials http://www.drugs.com/news/brain-tumor-vaccine-shows-promise-early-trials-30698.html Certain Diabetes Drugs Better for Heart Health, Study Finds http://www.drugs.com/news/certain-diabetes-better-heart-health-study-finds-30642.html Antibiotic-Resistant Bacteria in India Could Spread, Experts Say http://www.drugs.com/news/antibiotic-resistant-bacteria-india-could-spread-experts-say-30634.html Two Different Heart Drugs May Work Equally Well for High-Risk Patients http://www.drugs.com/news/two-different-heart-may-work-equally-well-risk-patients-30593.html Monthly Aspirin Use Linked to Lower Pancreatic Cancer Risk http://www.drugs.com/news/monthly-aspirin-linked-lower-pancreatic-cancer-risk-30535.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Recall: American Regent Injectable Products - Visible Particulates in Products http://www.drugs.com/fda/american-regent-injectable-products-recall-visible-particulates-products-12951.html Update of Healthcare Professional Information: Tysabri (natalizumab) http://www.drugs.com/fda/tysabri-natalizumab-update-healthcare-professional-12950.html New Safe Use Requirements: Long-Acting Beta-Agonists (LABAs) http://www.drugs.com/fda/long-acting-beta-agonists-labas-new-safe-requirements-12947.html Letter to Healthcare Professionals: Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals - Clogged, Blocked Oral Syringes and Feeding Tubes http://www.drugs.com/fda/lansoprazole-delayed-release-orally-disintegrating-teva-pharmaceuticals-letter-healthcare-12948.html Recall: Topamax (topiramate) - Musty Odor http://www.drugs.com/fda/topamax-topiramate-recall-musty-odor-12949.html Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults http://www.drugs.com/fda/tumor-necrosis-factor-tnf-blockers-azathioprine-mercaptopurine-update-reports-hepatosplenic-t-cell-12945.html Ongoing Safety Review: Benicar (olmesartan) http://www.drugs.com/fda/benicar-olmesartan-ongoing-safety-review-12946.html Ongoing Safety Review: Revlimid (lenalidomide) - Increased Risk of Developing New Malignancies http://www.drugs.com/fda/revlimid-lenalidomide-ongoing-safety-review-increased-risk-developing-new-malignancies-12942.html Benzocaine Topical Products - Risk of Methemoglobinemia http://www.drugs.com/fda/benzocaine-topical-products-gels-liquids-risk-methemoglobinemia-12941.html Risk Evaluation and Mitigation Strategy (REMS) - Yervoy (ipilimumab) Severe Immune-Mediated Adverse Reactions http://www.drugs.com/fda/yervoy-ipilimumab-risk-evaluation-mitigation-strategy-rems-severe-immune-mediated-adverse-reactions-12940.html Recall: Best Enhancer - Undeclared Drug Ingredient http://www.drugs.com/fda/best-enhancer-recall-undeclared-ingredient-12939.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 - 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