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Healthcare News Roundup: FDA

 HSMN NewsFeed - 24 Apr 2008
Akorn-Strides, LLC Announces FDA Approvals for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron Injection USP, 40 mg/20mL Multiple Dose Vials
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 23 Apr 2008
FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Apr 2008
Stem Cell Therapeutics Corp. Receives "May Proceed" From FDA for Its Phase IIb Clinical Stroke Trial and IND
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 23 Apr 2008
FDA Approval of Cimzia(R) for Crohn's Disease Represents Latest Milestone for Nektar's PEGylation Technology Platform
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 22 Apr 2008
Cimzia(R) Approved in the US for the Treatment of Moderate to Severe Crohn's Disease
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 22 Apr 2008
Archemix' ARC1779 Granted Orphan Designation for the Treatment of TTP, a Life-Threatening Blood Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Apr 2008
ImClone Announces Agreement with FDA on Special Protocol Assessment for Phase III Study of IMC-1121B in Breast Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 21 Apr 2008
BioMimetic Therapeutics Receives Written Communication from FDA Confirming Status of Ongoing Pivotal Trial for GEM OS1
Devices Orthopaedic
 HSMN NewsFeed - 21 Apr 2008
Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Transplantation
Devices Cardiology FDA
 HSMN NewsFeed - 21 Apr 2008
Mylan Announces Final FDA Approval for Felodipine Extended-Release Tablets, USP
Biopharmaceuticals FDA Generics
 HSMN NewsFeed - 21 Apr 2008
APP Pharmaceuticals Receives FDA Approval for Colistimethate For Injection, USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 21 Apr 2008
Watson Files FDA Application for Generic YASMIN(R)
Biopharmaceuticals Generics
 HSMN NewsFeed - 18 Apr 2008
Akorn, Inc. Announces FDA Approval of Diclofenac Sodium Ophthalmic Solution 0.1%
BIopharmaceuticals Generics Ophthalmology FDA
 HSMN NewsFeed - 17 Apr 2008
FDA Grants NeoVista's Request to Expand CABERNET Trial to 30 Sites in the U.S.
Devices Ophthalmology FDA
 HSMN NewsFeed - 17 Apr 2008
Dynavax and Merck & Co., Inc. Update Status of Clinical Hold of Investigational Vaccine HEPLISAV(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Apr 2008
Teva Announces Tentative Approval of Generic Maxalt(R) Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 17 Apr 2008
CryoLife to Distribute FDA-approved Hemostatic Agent Under Private Label
Devices Surgery Distribution
 HSMN NewsFeed - 17 Apr 2008
Response Biomedical Receives U.S. FDA 510(k) Market Clearance of Rapid Influenza A+B Test
Diagnostics FDA
 HSMN NewsFeed - 17 Apr 2008
Angiotech's novel 5-FU Central Venous Catheter receives FDA 510(k) clearance
Biopharmaceuticals Devices FDA
 HSMN NewsFeed - 17 Apr 2008
Accentia Announces that After Reviewing Unblinded Results, Independent DMC Recommends Presenting Data on BiovaxID(R) to FDA and Worldwide Regulatory Agencies in Order to Seek Marketing Approvals for Follicular Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 16 Apr 2008
FDA Approves Medtronic's Talent(TM) Abdominal Stent Graft for Repairing Aortic Aneurysms
Devices Interventional FDA
 HSMN NewsFeed - 16 Apr 2008
Neoprobe Receives Regulatory Clearance for Lymphoseek Clinical Study
Diagnostics FDA
 HSMN NewsFeed - 16 Apr 2008
Akorn, Inc. Announces FDA Approval of Ofloxacin Ophthalmic Solution USP, 0.3%
Biopharmaceuticals Generics FDA Ophthalmology
 HSMN NewsFeed - 15 Apr 2008
Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute Treatment of Migraine
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Apr 2008
Alcon's PATANASE(R) Nasal Spray Approved by FDA for Treatment of Nasal Allergy Symptoms
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Apr 2008
BSD Medical Submits 510(k) Premarket Notification for MicroThermX(R)-100 Microwave Ablation System
Devices Oncology FDA
 HSMN NewsFeed - 15 Apr 2008
Lev Pharmaceuticals Announces Submission of Complete Response to FDA for Cinryze(TM) for Hereditary Angioedema
Biopharmaceuticals
 HSMN NewsFeed - 15 Apr 2008
Kiadis Pharma Receives Orphan Drug Designation for Rhitol(TM) From the FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Apr 2008
St. Jude Medical Receives FDA and CE Mark Approvals for the World's Smallest, Longest-Lasting Rechargeable Neurostimulator to Treat Chronic Pain
Devices FDA
 HSMN NewsFeed - 10 Apr 2008
Hi-Tech Pharmacal Receives Tentative Approval for Dorzolamide Hydrochloride with Timolol Maleate Ophthalmic Solution
Biopharmaceuticals Generics Ophthalmology FDA
 HSMN NewsFeed - 10 Apr 2008
Corgenix Announces FDA Clearance for IgG Anti-AtherOx(R) Test Kit
Diagnostics FDA
 HSMN NewsFeed - 8 Apr 2008
U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Apr 2008
GlaxoSmithKline Confirms Receipt of FDA Letter on Regulatory Reporting
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Apr 2008
Collegium Pharmaceutical Announces FDA Filing for AllerNase(TM), a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Apr 2008
BRAHMS Receives FDA Clearance to Market Automated Procalcitonin (PCT) Test
Diagnostics FDA
 HSMN NewsFeed - 4 Apr 2008
iCAD Receives FDA Approval for Its SecondLook Digital for Use With Fuji's Digital Mammography System
Devices Radiology FDA
 HSMN NewsFeed - 3 Apr 2008
FDA Approves Rotarix(R) [Rotavirus Vaccine, Live, Oral], the First Vaccine Licensed to Complete the Rotavirus Immunization Series by Four Months of Age
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Apr 2008
Taro Receives Tentative FDA Approval for Lamotrigine Tablets ANDA
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 2 Apr 2008
Portrait(R) Plasma Receives Clearance from the FDA to Treat Acne Scars
Devices Dermatology FDA
 HSMN NewsFeed - 2 Apr 2008
Sirtris Receives Orphan Drug Designation from U.S. Food and Drug Administration for Resveratrol in Mitochondrial Disorder, MELAS Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Apr 2008
Imaging3 Receives FDA Approval to Distribute the Dominion Vi Scanner Under FDA (IDE) Regulations
Devices Radiology FDA
 HSMN NewsFeed - 1 Apr 2008
Supratek's lead compound SP1049C is granted Orphan Drug Designation for the treatment of gastric cancer.
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 1 Apr 2008
Labopharm Appeals FDA's Decision on Once-Daily Tramadol to Next Supervisory Level After Additional Analysis Supports Efficacy
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 Mar 2008
Mindray's Laptop-size M5 and BS-200 Receive FDA Clearance
Devices FDA
 HSMN NewsFeed - 31 Mar 2008
Kingfisher Healthcare (KFH) Receives FDA Clearance to Market KFH Energy in the USA And Raises EUR1 Million to Accelerate Market Penetration
Devices FDA
 HSMN NewsFeed - 28 Mar 2008
Lannett Company Receives FDA Approval for Bethanechol Chloride Tablets USP, 5 mg, 10 mg, 25 mg, and 50 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 28 Mar 2008
Actavis Receives Approval of Generic Wellbutrin SR(R) and Zyban(R) Tablets in the U.S.
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 28 Mar 2008
Toshiba Receives FDA Clearance for Two CT Clinical Applications
Devices Radiology FDA
 HSMN NewsFeed - 28 Mar 2008
BioMimetic Therapeutics Addresses FDA Communication on Regranex Safety Review
Biopharmaceuticals Wound Care
 HSMN NewsFeed - 27 Mar 2008
Pegintron(TM) Plus Weight-Based Rebetol(R) Resulted in Higher SVR Than Flat Dosing; Low Relapse Rates in Patients With Chronic Hepatitis C
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Mar 2008
Ethicon Endo-Surgery Submits Application to FDA for Approval of the SEDASYS(TM) System - the First Computer-Assisted Personalized Sedation System
Devices Drug Delivery Gastroenterology FDA
 HSMN NewsFeed - 26 Mar 2008
Cangene's anti-hepatitis B product granted orphan-drug exclusive approval by the U.S. Food and Drug Administration
Biopharmaceuticals FDA
 HSMN NewsFeed - 25 Mar 2008
Pioneer(R) Surgical Technology Receives 510(k) Clearance to Market Next Generation Pedicle Screw System
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 25 Mar 2008
ARCALYST(TM) (rilonacept), First and Only FDA-approved Treatment for Cryopyrin-Associated Periodic Syndromes (CAPS), Now Available in the United States
Biopharmaceuticals
 HSMN NewsFeed - 25 Mar 2008
Amrubicin(R) Receives FDA Orphan Drug Designation for the Treatment of Small Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 25 Mar 2008
Taro Receives FDA Approval for Ondansetron Hydrochloride Injection USP, 2 mg/mL ANDA
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 24 Mar 2008
CryoLife Announces Implant of First FDA-Cleared SynerGraft(R) Processed Human Pulmonary Heart Valve
Devices Cardiology
 HSMN NewsFeed - 24 Mar 2008
Pro-Pharmaceuticals Announces DAVANAT(R) Regimen Approved to Treat Breast Cancer Patient
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Mar 2008
Mentor Corporation Announces FDA Approval of Prevelle Silk: First Dermal Filler to Prove Pain Reduction in the U.S.
Biopharmaceuticals FDA Dermatology
 HSMN NewsFeed - 20 Mar 2008
Cephalon Receives FDA Approval for TREANDA, a Novel Chemotherapy for Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Mar 2008
Baxter Announces FDA Approval of ARTISS Slow-Setting Fibrin Sealant in Treatment of Burn Patients
Devices FDA
 HSMN NewsFeed - 20 Mar 2008
Smiths Medical Receives FDA Clearance for Next Generation CADD(R)-Solis Ambulatory Infusion System
Devices FDA
 HSMN NewsFeed - 20 Mar 2008
PLC Systems Receives FDA Approval to Commence Pivotal Study Of RenalGuard(TM) In the U.S.
Devices FDA
 HSMN NewsFeed - 19 Mar 2008
FDA Classifies Medtronic's Physician Communication Related to Inflammatory Mass Formation from Intrathecal Drug Therapy
Devices Drug Delivery Product Recall FDA
 HSMN NewsFeed - 19 Mar 2008
Cook Medical Receives FDA 510(k) Clearance for Celect(TM) Vena Cava Filter and Gunther Tulip(TM) Vena Cava Filter Retrieval Set
Devices FDA
 HSMN NewsFeed - 19 Mar 2008
Supplemental Application for GARDASIL(R), Merck's Cervical Cancer Vaccine, Designated Priority Review by the U.S. FDA for Use in Women 27 through 45
Biopharmaceuticals
 HSMN NewsFeed - 19 Mar 2008
Akorn-Strides, LLC Announces FDA Approval for Fosphenytoin Sodium Injection USP, 100 mg/2mL and 500 mg/10mL
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 19 Mar 2008
BIOLASE Announces FDA 510(k) Clearance of Its Waterlase(R) and Waterlase(R) MD Laser Systems for Root Canal Disinfection
Devices Dental FDA
 HSMN NewsFeed - 18 Mar 2008
Visionsense Announces Food and Drug Administration (FDA) 510(k) Clearance for VSII - Visionsense Stereoscopic Vision System
Devices FDA
 HSMN NewsFeed - 18 Mar 2008
Immunomedics' Milatuzumab Receives FDA Orphan Drug Designation for Therapy of Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Mar 2008
AtriCure's Coolrail(TM) Linear Ablation Pen Receives FDA 510(k) Clearance
Devices Cardiology FDA
 HSMN NewsFeed - 18 Mar 2008
FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Mar 2008
FDA issues Approvable Letter for ceftobiprole, a new anti-MRSA broad-spectrum antibiotic
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Mar 2008
Cordis Corporation Receives U.S. Food and Drug Administration Clearance for S.M.A.R.T. Nitinol Stent Transhepatic Biliary System for 120 mm and 150 mm Lengths
Devices Interventional FDA
 HSMN NewsFeed - 17 Mar 2008
Abiomed Receives Conditional FDA Approval for Impella 2.5 Study for Acute Myocardial Infarction (AMI) Patients
Devices Cardiology FDA
 HSMN NewsFeed - 17 Mar 2008
QLT announces positive FDA action on Aczone(TM)
Biopharmaceuticals
 HSMN NewsFeed - 17 Mar 2008
Tianyin Pharmaceutical Announces SFDA Approval to Market Azithromycin Dispersible Tablets
Biopharmaceuticals Generics Regulatroy
 HSMN NewsFeed - 17 Mar 2008
FDA Indicates That Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
Biopharmaceuticals Oncology
 HSMN NewsFeed - 17 Mar 2008
FDA Clears Expanded Use of Xoft's Axxent(R) Electronic Brachytherapy System for all Radiation Therapy Indications
Devices Oncology FDA
 HSMN NewsFeed - 17 Mar 2008
Apieron, Inc. Announces FDA Clearance of the Insight(TM) eNO System to Assist Physicians with Patient Asthma Management
Devices FDA
 HSMN NewsFeed - 14 Mar 2008
FDA Gives Go Ahead for Actavis' Irinotecan Hydrochloride Injection
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 13 Mar 2008
Hawthorn Pharmaceuticals, Inc. Receives FDA Approval on Granisol(TM) Oral Solution
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Mar 2008
Amgen to Discuss Benefits and Risks of ESA Treatment for Cancer Patients with Anemia Due to Chemotherapy at FDA ODAC Meeting
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 13 Mar 2008
FDA Approves Abbott's FreeStyle Navigator(R) Continuous Glucose Monitoring System
Devices FDA Endocrinology
 HSMN NewsFeed - 12 Mar 2008
VertiFlex Introduces the First Ever Percutaneous Dual Rod Accepting Polyaxial Screw
Devices FDA Orthopaedic Neurosurgery
 HSMN NewsFeed - 12 Mar 2008
Barr Receives Approval for Generic Taxol(R) Injection USP, 6mg/mL
Biopharmaceuticals Generics Oncology FDA
 HSMN NewsFeed - 12 Mar 2008
Amgen Statement on Successful Outcome of Romiplostim Panel Meeting
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Mar 2008
FDA Agrees to Amend Dendreon's Special Protocol Assessment for Phase 3 IMPACT Study of PROVENGE
Biopharmaceuticals Oncology
 HSMN NewsFeed - 11 Mar 2008
FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Mar 2008
Life Recovery Systems Study of Heart Attack With ThermoSuit(R) System
Devices Cardiology FDA
 HSMN NewsFeed - 11 Mar 2008
Schering-Plough Announces Filing of U.S. Application for OTC ZEGERID(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Mar 2008
Santarus Announces Submission of New Drug Application by Schering-Plough for ZEGERID Branded OTC Product
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Mar 2008
Totality of Available Data Reaffirms PROCRIT(R) (Epoetin alfa) Is Safe and Effective When Used Appropriately as Labeled to Treat Chemotherapy-Induced Anemia
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Mar 2008
Auriga Laboratories Announces FDA Approval of Liquadd(TM) (Dextroamphetamine Sulfate) Oral Solution for the Treatment of ADHD and Upcoming Product Launch
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Mar 2008
Life Spine Adds New Lynx(TM) Cross Connector to Its Lumbar Fixation Offering
Devices Orthopaedic FDA
 HSMN NewsFeed - 10 Mar 2008
Laborie Medical Technologies Receives FDA Pre-Market Clearance for TETRA(TM)- NIRS Accessory for the US Market
Devices Urology FDA
 HSMN NewsFeed - 7 Mar 2008
FDA Approves New Drug Application (NDA) for LEVOleucovorin, Spectrum's First Proprietary Oncology Drug
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Mar 2008
Amgen Announces Update to U.S. Prescribing Information for Aranesp(R) and EPOGEN(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Mar 2008
Sorin Group Announces FDA Approval of New Defibrillation Leads Range: ISOLINE(TM)
Devices FDA
 HSMN NewsFeed - 5 Mar 2008
FDA Accepts for Review Theravance's Complete Response to Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Mar 2008
Iverson Genetic Diagnostics Offers FDA Cleared Warfarin Test
Diagnostics FDA
 HSMN NewsFeed - 4 Mar 2008
Osteotech Receives FDA Clearance for Plexur M(TM) Biocomposite
Devices Regenerative Medicine Orthopaedic FDA
 HSMN NewsFeed - 4 Mar 2008
Roche Statement Regarding Tamiflu U.S. Label Revision
Biopharmaceuticals FDA
 HSMN NewsFeed - 4 Mar 2008
FDA Grants Market Clearance to Aerocrine Inc.'s NIOX MINO(R): a New Hand-Held Device to Measure Airway Inflammation in Asthma
Devices FDA
 HSMN NewsFeed - 3 Mar 2008
ContraVac Receives FDA Approval for Post-Vasectomy Home Sperm Test
Diagnostics
 HSMN NewsFeed - 3 Mar 2008
Draeger's SmartCare(R)/PS Reduces Overall Ventilation Time 33%, Weaning Time up to 40% and ICU Length of Stay to 20%
Devices FDA
 HSMN NewsFeed - 3 Mar 2008
FDA Grants Priority Review for PROMACTA(R) (eltrombopag)
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Mar 2008
Endo Pharmaceuticals to Launch Three New Dosage Strengths of OPANA(R) ER
Biopharmaceuticals Pain Management FDA
 HSMN NewsFeed - 2 Mar 2008
FDA Approves Aloxi(R) (Palonosetron HCL) Injection for Prevention of Postoperative Nausea and Vomiting
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Feb 2008
Fujifilm Receives FDA Clearance for Unity SpeedSuite(TM)
Devices Radiology FDA
 HSMN NewsFeed - 29 Feb 2008
U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Feb 2008
FDA Grants CLIA Waiver for Quidel's QuickVue(R) RSV Test
Diagnostics FDA
 HSMN NewsFeed - 28 Feb 2008
FDA Approves LUVOX(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Feb 2008
FDA Approves NEXIUM(R) for the Treatment of Short-Term GERD in Children 1 to 11 Years Old
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 28 Feb 2008
Teva Announces Approval of Generic Camptosar(R)
Biopharmaceuticals Generics Oncology FDA
 HSMN NewsFeed - 28 Feb 2008
CAS Medical Systems, Inc. Announces FDA 510(k) Clearance for Neonatal FORE-SIGHT Cerebral Oximeter
Devices Monitoring FDA
 HSMN NewsFeed - 28 Feb 2008
FDA Issues Not-Approvable Letter for Lilly's Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
Biopharmaceuticals FDA
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