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January, 2012
January, 2012:
RECALL: Renastart Medical Food Cans Incorrectly Labeled
Kalydeco Approved to Treat Underlying Cause of Cystic Fibrosis
High-Fiber Diet May Not Lower Risk of Diverticulosis
Fructose Linked to Increased Cardiometabolic Risk in Teens
Site of Fatty Acid Storage in the Body Varies With Activity
Physician Overweight/Obesity Impacts Obesity Care
Similar Morbidity for Robotic, Laparoscopic Hysterectomy
Warm Saline Enhances Shoulder Tendinitis Treatment
Phase 2 Trial of AGS-003 with Sunitinib for Advanced Renal Cell Carcinoma
NDA Accepted for Gattex for Adult Short Bowel Syndrome
Jentadueto Approved for Type 2 Diabetes
Hi-Tech Pharmacal Receives FDA Approval for Lorazepam Oral Concentrate
Antiretroviral Medications Linked to Cleft Deformities
Erivedge Approved for Advanced Basal Cell Carcinoma
Meta-Analysis: Statin Therapy Equally Effective in Women, Men
FDA Approves Lannett's ANDA Supplement for Phentermine HCl Capsules
Fever, Epidural Combo Ups Adverse Neonatal Outcomes
More Research Needed on Weaning of Addicted Infants
Eye Contact Abnormal in Infants at Risk for Autism
Disc Degeneration More Likely in Overweight, Obese Adults
Differing Arm Blood Pressure Linked to Vascular Disease, Death
Lannett Receives FDA Approval for HCTZ 12.5mg Capsules
RECALL: Treanda Recalled Due to Particulate Matter in Vial
Tisseel Gains Indication for General Hemostasis in Surgery
Bydureon Approved for Once-Weekly Treatment of Type 2 Diabetes
Isoflurane Harmful to Mitochondrial Function in Mice
Self-Rated Health Status Predicts Mortality Among CVD Patients
Inlyta Approved for Advanced Renal Cell Carcinoma
Steroid-Sparing Renal Transplant Yields Successful Outcomes
Warfarin Use Lowers Mortality in Septuagenarians With A-Fib
NDA Accepted for Bosutinib for Previously Treated Ph+ Chronic Myeloid Leukemia
Phase 2 Trial Update of Adcetris in Cutaneous T-Cell Lymphoma
ACE Inhibitors Not Linked to Improved Outcomes After ACS
Anaphylactic Shock After Immunizations Is Rare
Positive Affirmation Improves Medication Adherence
Exposure to Iodinated Contrast Media Affects Thyroid Function
Phase 3 Study of Tysabri for Secondary-Progressive Multiple Sclerosis
Phase 2 Trial Update of ADXS-HPV in Recurrent/Refractory Cervical Cancer
Phase 3 Study Update of Tasimelteon for Non-24-Hour Sleep-Wake Disorder
Keppra Gains Indication for Infants and Children with Partial Onset Seizures
Sildenafil Shows Potential for Lymphatic Malformations
Risk-Factor Burden Impacts Lifetime Risk of Cardio Disease
Phase 2 Study of CMX001 for Prophylaxis of Cytomegalovirus in Hematopoietic Stem Cell Transplant Recipients
Foods Fried in Olive Oil Not Linked to Heart Disease
Vytorin Labeling Updated to Include New Study Data in CKD Patients
Fast Track Designation for NBI-98854 for Neuroleptic-Induced Tardive Dyskinesia
Perfluorinated Compounds Reduce Immunity in Children
Picato Gel Approved for Actinic Keratoses
Lansoprazole Does Not Improve Asthma Control in Children
Phase 2 Study of Cabozantinib for Hepatocellular Carcinoma
Phase 3 Study Update of Regorafenib for Metastatic Colorectal Cancer
National Adolescent Hep A Vaccine Coverage Is Low
Orphan Drug Designation for Inhaled Nitric Oxide in Pulmonary Arterial Hypertension
Premixed Levetiracetam Available in Ready-to-Administer IV Bags
Cefazolin 2g Formulation Approved
Additional Route of Administration Approved for Velcade
Chlorhexidine Erases More of Preoperative Skin Markings
Sleep Disturbance Linked to Cardiometabolic Disease Risk
Inadequate Hep B Vaccinations for High-Risk Adults
Dosing Errors Occur With IV Acetaminophen in Children
Perrigo Confirms Filing of Generic Version of Astepro Nasal Spray
B-Nexa Prenatal Vitamin with B Vitamins and Ginger for Nausea and Vomiting Available
Tysabri Labeling to Include Anti-JCV Antibody Status as PML Risk Factor; Stratify JCV Antibody ELISA Test Approved
SSRIs Increase Fall Risk in Elderly Dementia Patients
Neuromodulators Reduce Pain in Rheumatoid Arthritis
Cancer Prevention Guidelines Updated
No Autoimmune Safety Signal for Quadrivalent HPV Vaccine
Calcium Associated With Lower Risk of Prostate Cancer
ASCO: Regorafenib Improves Survival in Metastatic CRC
Warfarin Patients With Head Trauma Need Second CT Scan
Long-Term Adalimumab Safe, Effective for Psoriasis
Contraceptives Eschewed by Half of Teenage Mothers
Sexual Activity Safe for Most Cardiovascular Disease Patients
Worse Outcomes for Stroke Patients With Delirium
BRAF & MEK Inhibitor May Help Avoid Cutaneous Carcinomas
Upper Normal BP Increases Risk for A-Fib in Men
Chronic Hepatitis C May Benefit From New Antivirals
FIRST Omeprazole and FIRST Lansoprazole Compounding Kits Available
New Formulations of Viread Approved for Children with HIV-1
Bevacizumab Combo Improves Colorectal Cancer Survival
Circulating Tumor Cells Predict Small-Cell Lung CA Prognosis
Dual Inhibition of HER2 Beats Single Agent in Breast Cancer
Hylase Wound Gel Available
ROR2 ID'd As Novel Biomarker of Soft-Tissue Sarcomas
Meningitis B Vaccine Immunogenic in Adolescents
GE100 Blood Glucose Monitoring System Available
Patients With Breast Cancer Lack Knowledge of the Disease
Platelet Inhibition Maintained With Pre-CABG Cangrelor
Voraxaze Approved to Treat Methotrexate Toxicity
No Long-Term Benefit of Caffeine for Apnea in Preemies
Watson Launches Vestura, Generic Version of Yaz
MetroGel 1% Now Available in a Pump
Low Doses of Insulin Induce an Elastogenic Effect
Phase 2 Study of Tivantinib for Hepatocellular Carcinoma
Phase 3 Study of Avanafil for Erectile Dysfunction
Untreated Sleep Apnea Linked to Cardio Mortality in Women
Vitamin D Supplements Do Not Reduce COPD Exacerbations
Additional Mutations Identified in Relapse-Specific AML
No Mortality Benefit for Annual Prostate Cancer Screening
Maternal Asthma Meds Not Linked to Most Birth Defects
Antiestrogens May Counter Increased Skin Cancer Risk
Hyaluronic Acid Similar to Placebo for Ankle Arthritis
Change in Bone Scan Index Predicts Prostate CA Survival
Practice Differs for Cardiac Screening in ADHD Treatment
Varicose Veins Patient Information Fact Sheet
Scaly Scalp Patient Information Fact Sheet
Psoriasis Patient Information Fact Sheet
Eczema Patient Information Fact Sheet
Athlete's Foot Patient Information Fact Sheet
Maternal Antidepressants Up Infant Pulmonary Hypertension
Adcetris Prescribing Information Updated
Take Our Survey and You Could Win an iPad 2
SAFETY ALERT: Guidance Issued for Recall on Polymyxin B and Vecuronium
GLP-1R Agonists Found Effective for Weight Loss
Physical Activity in Work or Leisure Tied to Lower MI Risk
Prasco Launches Authorized Generic of Carbatrol
Lidocaine Plus Heparin Provides Fast Relief of Pain, Urgency of Interstitial Cystitis
Subclinical Tachyarrhythmias Tied to Increased Risk of Stroke
Single Oral Azithromycin Dose Effective for Yaws
Hypertension Registry IDs Features of Pediatric HTN
Complications Increase With Delay of BP Control in Diabetes
Tourette Syndrome Patient Information Fact Sheet
Multiple Sclerosis Patient Information Fact Sheet
Polyps Patient Information Fact Sheet
Gallstones Patient Information Fact Sheet
No Rise in Intussusception After Rotavirus Shot Revival
Diverticulitis and Diverticular Disease Patient Information Fact Sheet
Resubmitted NDA Accepted for Lorcaserin for Weight Management
Benefit of Aspirin in Primary Prevention Questioned
Nicotine Replacement Therapy Doesn't Avert Smoking Relapse
Colorectal Cancer Patient Information Fact Sheet
Transdermal Nicotine May Benefit Cognitive Impairment
Memantine Has No Impact on Cognition in Down's Syndrome
Too High, Too Low Serum Potassium Linked to Mortality
Huntington's Disease Patient Information Fact Sheet
Epilepsy Patient Information Fact Sheet
Sleep Disorders Patient Information Fact Sheet
Schizophrenia Patient Information Fact Sheet
Parkinson's Disease Patient Information Fact Sheet
Obsessive-Compulsive Disorder (OCD) Patient Information Fact Sheet
Narcolepsy Patient Information Fact Sheet
Depression Patient Information Fact Sheet
Long-Term Prognostic Value of Dobutamine Stress Echo Limited
A Broken Heart Does Increase Heart Attack Risk
Attention Deficit Hyperactivity Disorder (ADHD) Patient Information Fact Sheet
Testicular Cancer Patient Information Fact Sheet
OneTouch VerioIQ System Blood Glucose Monitor Available
Urinary Incontinence Patient Information Fact Sheet
Statins Increase Diabetes Risk for Postmenopausal Women
Ulcerative Colitis Patient Information Fact Sheet
Hemorrhoids Patient Information Fact Sheet
Erectile Dysfunction Patient Information Fact Sheet
Benign Prostatic Hyperplasia (BPH) Patient Information Fact Sheet
Rheumatoid Arthritis Patient Information Fact Sheet
Osteoarthritis Patient Information Fact Sheet
Rilonacept Reduces Gout Flares During Acute Urate Lowering Therapy
Ped Heart Surgery Deaths Higher at Low Volume Centers
SAFETY ALERT: Packaging Errors for Opiate Products from Endo by Novartis Consumer Health
sBLA Submitted for Gammagard Liquid for Multifocal Motor Neuropathy
RECALL: Novartis Recalls Select Excedrin, NoDoz, Bufferin, and Gas-X Prevention Products
Onfi Available for Lennox-Gastaut Syndrome
Frequent Aspirin Use Linked to Aging Macular Disorder
Phase 3 Study of Posidur for Post-Op Pain Relief
Intrapartum Antibiotics Reduce Infant Strep B Infection Globally
Novel Hepatitis C Vaccine Induces T Cell Responses
Epilepsy, HIV Drug Combination Therapies Require Caution
Fast Track Designation for AC607 for Acute Kidney Injury
Vaccine Helps Prevent HSV-1 Genital Disease and Infection
Ankylosing Spondylitis Patient Information Fact Sheet
Montelukast Doesn't Cut Upper Respiratory Infection Incidence
Sciatica Patient Information Fact Sheet
Migraine Patient Information Fact Sheet
Gout Patient Information Fact Sheet
Back Pain Patient Information Fact Sheet
Actavis Launches Generic Version of Ritalin LA
Orphan Drug Designation for HT-100 for Duchenne Muscular Dystrophy
Epidural Steroids Temporarily Up Blood Glucose in Diabetes
Expanded Label for Berinert Approved
Hormone Receptor Levels Predict Trastuzumab Effect
FDA Approves Single REMS for Transmucosal Immediate-Release Fentanyl Products
Phase 3 Study of Tivozanib for Advanced Renal Cell Cancer
Prevnar 13 Approved for Pneumonia Immunization in Adults ≥50 Years
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