Healthcare Sales & Marketing Network: FDA : Medical Device and Pharmaceutical News

Healthcare News Roundup: FDA

HSMN NewsFeed - 18 Jun 2008
HemoCue Receives First FDA CLIA Waiver in Diagnostics Industry for Quantitative Point-of-Care Test for Microalbuminuria, a Kidney and Cardiovascular Disease Risk Marker
Diagnostics

HSMN NewsFeed - 17 Jun 2008
FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology

HSMN NewsFeed - 17 Jun 2008
MEDRAD Receives FDA 510(k) Clearance for FDG Infusion System
Devices Radiology FDA

HSMN NewsFeed - 17 Jun 2008
NeoMend Receives FDA Panel's Recommendation for Approval of ProGEL(TM) Surgical Sealant
Devices Surgery FDA

HSMN NewsFeed - 16 Jun 2008
Allergan Receives U.S. Food and Drug Administration Approval for TRIVARIS(TM) (triamcinolone acetonide injectable suspension) 80 mg/mL
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 16 Jun 2008
Mylan Announces Tentative FDA Approval for Generic Version of Antihypertensive Avalide(R) Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 16 Jun 2008
Mylan Announces Final FDA Approval for Generic Version of Antidepressant Effexor(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 16 Jun 2008
FDA Approves Cymbalta(R) for the Management of Fibromyalgia
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Jun 2008
Elekta VMAT 510(K) Clearance Welcomed by US Radiation Oncologists
Devices FDA Oncology

HSMN NewsFeed - 13 Jun 2008
U.S. FDA Approves Requip(R) XL(TM), the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 12 Jun 2008
Mindray's AS3000(TM) Anesthesia Delivery System Receives U.S. FDA Clearance
Devices FDA

HSMN NewsFeed - 12 Jun 2008
Teva Announces Tentative Approval of Generic Diovan(R) Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 9 Jun 2008
Siemens SOMATOM Definition AS Receives FDA Clearance
Devices Radiology FDA

HSMN NewsFeed - 9 Jun 2008
Cook Medical Announces FDA 510(k) Clearance of Evolution(R) Controlled Release Esophageal Stent System
Devices Interventional Oncology FDA

HSMN NewsFeed - 9 Jun 2008
Raptor Pharmaceuticals Corp. Receives FDA Orphan Drug Designation for Cysteamine in Huntington's Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 6 Jun 2008
Mindray's DC-3 Color Ultrasound Gains U.S. FDA 510(k) Clearance
Devices FDA

HSMN NewsFeed - 6 Jun 2008
US FDA grants pediatric exclusivity for UCB's Keppra(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Jun 2008
Medtronic Receives FDA Approval for Talent(TM) Thoracic Stent Graft as Minimally-Invasive Treatment for Aortic Disease
Devices Interventional FDA

HSMN NewsFeed - 5 Jun 2008
FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Jun 2008
New Drug Application Filing for Levoleucovorin Tablets Completed by Spectrum Pharmaceuticals, Inc.
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 4 Jun 2008
Korean FDA Approves the CereTom(R) Portable CT Scanner
Devices Regulatory Radiology

HSMN NewsFeed - 4 Jun 2008
Amgen and Wyeth Statement on the FDA Early Communication About Tumor Necrosis Factor (TNF) Blockers
Biopharmaceuticals

HSMN NewsFeed - 4 Jun 2008
Draeger Announces FDA Clearance for New Ventilator - Carina(TM)
Devices FDA

HSMN NewsFeed - 4 Jun 2008
AstraZeneca Submits an sNDA for SYMBICORT(R) for the Treatment of Asthma in Children as Young as Age Six
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Jun 2008
Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Jun 2008
LifeWatch Corp. Parent Company, Card Guard AG Receives Full FDA Clearance for Next-Generation LifeStar ACT III Platinum System
Devices Cardiology Monitoring FDA

HSMN NewsFeed - 3 Jun 2008
Invitrogen Receives FDA Clearance for Diagnostic System to Determine Transplant Compatibility
Diagnostics FDA

HSMN NewsFeed - 3 Jun 2008
Watson Receives FDA Approval of Potassium Chloride Extended-Release Capsules
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 3 Jun 2008
Anesiva Announces South Korea FDA Approval of Adlea(TM) Investigational New Drug Application
Biopharmaceuticals Regulatory

HSMN NewsFeed - 3 Jun 2008
Bovie Medical Announces Market Release of Canady APC Probes; FDA Submission of MEG Laparoscopic Instrument Line
Devices Surgery

HSMN NewsFeed - 3 Jun 2008
Lexicon's Drug Candidate for Carcinoid Syndrome Receives Fast Track Status From the FDA
Biopharmaceuticals

HSMN NewsFeed - 2 Jun 2008
Banner Pharmacaps Receives FDA Approval for Amantadine Softgel Capsules
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 2 Jun 2008
Watson Receives Final Approval of Omeprazole Delayed-Release Capsules
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 2 Jun 2008
Abiomed Receives 510(k) Clearance from FDA for Impella 2.5 Device
Devices Cardiology FDA

HSMN NewsFeed - 30 May 2008
Teva Announces Launch of Generic Wellbutrin XL(R) Tablets, 150 mg
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 30 May 2008
Lupin Receives USFDA Approval for Topiramate Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 29 May 2008
Alma Lasers Announces FDA Clearance of the Harmony(XL) Multi-Application System at THE Aesthetic Show 2008
Devices Dermatology FDA

HSMN NewsFeed - 29 May 2008
Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia
Biopharmaceuticals FDA

HSMN NewsFeed - 28 May 2008
The Medicines Company Receives FDA Review Letter for Angiomax Supplemental Filing
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 27 May 2008
Somanetics Receives 510(k) Clearance From the FDA to Expand INVOS System Labeling
Devices Monitoring FDA

HSMN NewsFeed - 27 May 2008
Collagen Matrix, Inc. Receives FDA 510(k) Clearance for TenoMend(TM) Collagen Tendon Wrap for the Management and Protection of Tendon Injuries
Devices Orthopaedic FDA

HSMN NewsFeed - 27 May 2008
ZymoGenetics Announces FDA Approval of RECOTHROM(TM) 20,000-IU Vial Size and Co-Packaging with Spray Kit
Biopharmaceuticals FDA

HSMN NewsFeed - 23 May 2008
Osmotica Pharmaceutical Receives FDA Approval to Market Novel Forms of Extended Release Venlafaxine HCl
Biopharmaceuticals FDA

HSMN NewsFeed - 23 May 2008
Lutronic Inc. Announces FDA Clearance of Its Spectra VRM III Q-Switched Nd:Yag Laser System for Treating a Broad Spectrum of Dermatological and Aesthetic Conditions
Devices Dermatology FDA

HSMN NewsFeed - 23 May 2008
Cook Medical Receives FDA Approval for Advanced Thoracic Aortic Aneurysm Endovascular Graft
Devices Interventional FDA

HSMN NewsFeed - 23 May 2008
Wyeth Receives Approvable Letter From FDA for Bazedoxifene for the Treatment of Postmenopausal Osteoporosis
Biopharmaceuticals FDA

HSMN NewsFeed - 23 May 2008
Akorn-Strides, LLC Announces FDA Approval for Rifampin for Injection USP, 600 mg/Vial
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 21 May 2008
FDA Clears New Applicators for Endometrial Cancer Treatment With Xoft's Axxent(R) Electronic Brachytherapy System
Devices Oncology FDA

HSMN NewsFeed - 20 May 2008
Adolor and GlaxoSmithKline Announce FDA Approval of Entereg(R) (alvimopan) for the Management of Postoperative Ileus (POI)
Biopharmaceuticals FDA

HSMN NewsFeed - 20 May 2008
Covidien Receives FDA Clearance to Market Single-Incision Laparoscopic Surgery (SILS(TM)) Kit
Devices Surgery FDA

HSMN NewsFeed - 19 May 2008
Bayer Announces Availability of Reformulated Liquid Leukine(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 19 May 2008
InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 19 May 2008
FDA Clears Calypso(R) Medical's GPS for the Body(R) for Prostatectomy Patients
Devices Oncology FDA

HSMN NewsFeed - 18 May 2008
Spirus Medical Announces 510(k) Clearance from FDA for Expanded Use of Endo-Ease(R) Discovery SB(TM)
Devices FDA Gastroenterology

HSMN NewsFeed - 16 May 2008
FDA Grants Approval to Begin Landmark Cardiac Resynchronization Therapy Study, EchoCRT
Devices Cardiology FDA

HSMN NewsFeed - 16 May 2008
Boston Scientific Announces FDA Approval of New Heart Failure Lead
Devices Cardiology FDA

HSMN NewsFeed - 15 May 2008
Sorin Group Announces FDA Approval of the World's Smallest Cardiac Resynchronization Implantable Cardioverter Defibrillator: OVATIO(TM) CRT
Devices Cardiology FDA

HSMN NewsFeed - 15 May 2008
KV Pharmaceutical Company Announces Approval for the 50 mg Strength of Generic Version of Toprol-XL(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 15 May 2008
St. Jude Medical Announces FDA Clearance and European CE Mark Approval for Tools That Help Place Leads in Challenging Heart Anatomy
Devices Cardiology FDA Regulatory

HSMN NewsFeed - 15 May 2008
Valeant Pharmaceuticals Announces FDA Has Initiated Reconsideration of Generic Efudex(R) Approval
Biopharmaceuticals Generics Dermatology FDA

HSMN NewsFeed - 15 May 2008
Terguride Receives FDA Orphan Drug Designation for the Treatment of Pulmonary Arterial Hypertension
Biopharmaceuticals FDA

HSMN NewsFeed - 14 May 2008
Masimo Receives FDA Clearance for Noninvasive Total Hemoglobin
Devices Monitoring FDA

HSMN NewsFeed - 14 May 2008
FDA Approves AstraZeneca's Seroquel(R) for Maintenance Treatment in Bipolar Disorder
Biopharmaceuticals FDA

HSMN NewsFeed - 14 May 2008
Advanced Medical Optics Receives FDA Clearance For iFS(TM) Advanced Femtosecond Laser
Devices Ophthalmology

HSMN NewsFeed - 14 May 2008
Simcere Pharmaceutical Group Announces SFDA Approval of First-to-Market Generic Biapenem Injection Anxin
Biopharmaceuticals Generics Regulatory

HSMN NewsFeed - 13 May 2008
Boston Scientific Announces FDA Approval for New Devices to Treat Heart Failure and Sudden Cardiac Death
Devices Cardiology FDA

HSMN NewsFeed - 13 May 2008
St. Jude Medical Announces FDA and European CE Mark Approvals of the IsoFlex Optim Pacing Lead
Devices Cardiology FDA

HSMN NewsFeed - 13 May 2008
PhotoMedex Receives FDA Clearance for the XTRAC(R) Velocity(TM) Laser
Devices Dermatology FDA

HSMN NewsFeed - 13 May 2008
Medtronic Announces FDA Approval of New Vision 3D Wireless Implantable Cardiac Devices
Devices Cardiology FDA

HSMN NewsFeed - 13 May 2008
FDA Approves NOVO NORDISK's NovoSeven(R) RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients With Inhibitors
Biopharmaceuticals FDA

HSMN NewsFeed - 13 May 2008
Spinal Restoration, Inc. Receives FDA IDE Approval
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 13 May 2008
Cipher provides regulatory update for CIP-TRAMADOL ER
Biopharmaceuticals FDA

HSMN NewsFeed - 12 May 2008
St. Jude Medical Announces FDA Approval of Next-Generation Remote Monitoring and Data Management System for Implantable Cardiac Devices
Devices Cardiology

HSMN NewsFeed - 12 May 2008
Pipex Pharmaceuticals Receives FDA Orphan Drug Designation for Oral TTM for Idiopathic Pulmonary Fibrosis (IPF)
Biopharmaceuticals FDA

HSMN NewsFeed - 12 May 2008
Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Assist Device
Devices FDA

HSMN NewsFeed - 12 May 2008
Novalar Receives FDA Approval for OraVerse(TM)
Biopharmaceuticals FDA Dental

HSMN NewsFeed - 9 May 2008
ZIOPHARM Receives FDA Orphan Drug Designation for Palifosfamide (ZIO-201) in the Treatment of Soft Tissue Sarcoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 May 2008
FDA Grants Priority Review of Gamunex(R) as a Treatment for Neurological Disorder CIDP
Biopharmaceuticals FDA

HSMN NewsFeed - 8 May 2008
Boston Scientific Announces FDA Approval of New Family of Advanced Pacemakers
Devices Cardiology FDA

HSMN NewsFeed - 8 May 2008
CorMatrix(R) Announces FDA 510(k) for Novel Biomaterial Implant for Intracardiac Repair
Devices Cardiology FDA

HSMN NewsFeed - 8 May 2008
FDA Approves Strattera(R) for Maintenance of ADHD in Children and Adolescents
Biopharmaceuticals FDA

HSMN NewsFeed - 8 May 2008
Atrium Medical Receives FDA Approval for its Novel C-QUR Lite(TM) V-Patch and C-QUR Edge(TM) V-Patch
Devices FDA

HSMN NewsFeed - 8 May 2008
Osiris Receives Approval for Use of Prochymal(TM) Under FDA Expanded Access Treatment Program
Regenerative Medicine FDA

HSMN NewsFeed - 7 May 2008
Mylan Announces Final FDA Approval for Ropinirole Hydrochloride Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 6 May 2008
Cephalon Announces FDA Advisory Committee Recommendation Against Approval of an Expanded Label for FENTORA
Biopharmaceuticals FDA

HSMN NewsFeed - 6 May 2008
Vascular Insights Receives FDA Clearance for Infusion Catheter
Devices Interventional FDA

HSMN NewsFeed - 6 May 2008
Prostate Cancer Breakthrough Receives FDA Clearance
Devices Urology FDA

HSMN NewsFeed - 6 May 2008
Scient'x Announces FDA 510(K) Clearance for Isobar DUO(TM) Dynamic Stabilization System
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 6 May 2008
Lev Pharmaceuticals Announces Cinryze(TM) Complete Response Submission Accepted for Review by FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 5 May 2008
HeartWare Receives Conditional Approval of IDE
Devices Cardiology FDA

HSMN NewsFeed - 5 May 2008
FDA Gives Green Light to GE Healthcare Surgery; Shipping Resumes
Devices Radiology

HSMN NewsFeed - 5 May 2008
ParagonDx Receives FDA 510(k) Marketing Clearance for Warfarin Sensitivity Genotyping Kit
Diagnostics FDA

HSMN NewsFeed - 5 May 2008
Gore Receives Approval From FDA For Unique Patent Foramen Ovale Stroke Study
Devices Cardiology FDA

HSMN NewsFeed - 5 May 2008
Advantage Medical Devices Receives FDA Clearance for VantageCath(TM)
Devices FDA

HSMN NewsFeed - 2 May 2008
Lev Announces FDA Advisory Committee Unanimously Recommends Approval of Cinryze(TM) for Hereditary Angioedema
Biopharmaceuticals FDA

HSMN NewsFeed - 2 May 2008
Stryker's Biotech Division Receives FDA Warning Letter
Devices FDA

HSMN NewsFeed - 1 May 2008
Angiotech Expands Quill(TM) SRS product offering receiving FDA 510(k) approval for smaller size diameters of Quill(TM) SRS PDO
Devices FDA

HSMN NewsFeed - 1 May 2008
Syneron's LipoLite(TM) Minimally Invasive Laser-Assisted Lypolysis Receives FDA Clearance
Devices Dermatology FDA

HSMN NewsFeed - 1 May 2008
AngioScore Receives FDA Clearance to Market AngioSculpt PTA Scoring Balloon Catheter for Additional Peripheral Indications
Devices Interventional FDA

HSMN NewsFeed - 30 Apr 2008
FDA Approves Advair(R) 250/50 for Reduction of Exacerbations in Patients With COPD
Biopharmaceuticals FDA

HSMN NewsFeed - 30 Apr 2008
FDA Approves MIXJECT(TM), a Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceutical's TRELSTAR(R) DEPOT and TRELSTAR(R) LA
Biopharmaceuticals Devices Drug Delivery Oncology FDA

HSMN NewsFeed - 29 Apr 2008
Medtronic Receives Approval to Market Smaller Kit Sizes of INFUSE(R) Bone Graft
Devices Orthopaedic FDA

HSMN NewsFeed - 29 Apr 2008
FDA Grants Market Clearance for the LipiScan(TM) Coronary Imaging System Developed by InfraReDx, Inc. - A Novel Spectroscopy System for the Identification of Lipid Core Containing Plaques of Interest in the Coronary Arteries
Devices Cardiology FDA

HSMN NewsFeed - 29 Apr 2008
Mylan Announces Final FDA Approval for Trandolapril Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 28 Apr 2008
Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant)
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Apr 2008
Teva Announces Approval of Generic Flolan(R) for Injection
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 28 Apr 2008
NeuroMetrix Receives FDA 510(k) Clearance for the ADVANCE(TM) System for the Performance of Nerve Conduction Studies and Needle Electromyography Procedures
Devices FDA

HSMN NewsFeed - 28 Apr 2008
Nihon Kohden America, Inc. Announces FDA 510K Clearance of the Prefense(TM) Early Detection and Notification System(TM)
Devices Monitoring FDA

HSMN NewsFeed - 28 Apr 2008
Medtronic Announces FDA Clearance of New OneTouch(R) UltraLink(TM) Blood Glucose Meter
Devices Monitoring Endocrinology FDA

HSMN NewsFeed - 28 Apr 2008
Derma Sciences Receives Third FDA Clearance for MEDIHONEY(TM) Wound & Burn Dressings
Devices Wound Care FDA

HSMN NewsFeed - 28 Apr 2008
Physio-Control and FDA Agree on Plan to Address Quality System Issues
Devices Cardiology FDA

HSMN NewsFeed - 28 Apr 2008
DynaMed Systems Obtains FDA Approval to Study Its Traxon(R) Spinal Cord Repair Stimulation System in Acute Spinal Cord Injured (SCI) Patients
Devices Neurosurgery FDA

HSMN NewsFeed - 25 Apr 2008
FDA Provides Clarity to Isis Regarding the Development Path for Mipomersen
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Apr 2008
Jerini Receives Positive CHMP Opinion Recommending European Approval for Icatibant in the Treatment of HAE; FDA Issues Not Approvable Letter
Biopharmaceuticals Regulatory

HSMN NewsFeed - 24 Apr 2008
Lannett Company Receives Approval for Dipyridamole Tablets USP, 25 mg, 50 mg, and 75 mg
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 24 Apr 2008
Jerini AG -- FDA Issues Not Approvable Letter for Icatibant in the Treatment of HAE
Biopharmaceuticals 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

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