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

Healthcare News Roundup: FDA

HSMN NewsFeed - 24 Jul 2006
TyRx Pharma, Inc., Announces FDA Clearance of PIVIT(TM) AB, a Novel Antimicrobial-Coated Surgical Mesh
Devices Surgery FDA

HSMN NewsFeed - 20 Jul 2006
Hutchinson Technology Receives FDA Clearance for InSpectra(TM) StO2 Tissue Oxygenation Monitor
Devices Monitoring FDA

HSMN NewsFeed - 20 Jul 2006
AtriCure Receives FDA 510(k) Clearance for Multifunctional Isolator(TM) Transpolar (TM) Pen System and Releases New Isolator Transpolar Open Clamp
Devices Cardiology FDA

HSMN NewsFeed - 20 Jul 2006
Teva Announces Final Approval of Meloxicam Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 20 Jul 2006
SmartPill Wins 510(k) Release from FDA
Devices Gastroenterology FDA

HSMN NewsFeed - 19 Jul 2006
FDA Approves Expansion of Cardiovascular Systems Inc. Clinical Trial of the Orbital Atherectomy System for Treatment of Peripheral Vascular Stenosis (OASIS)
Devices Interventional

HSMN NewsFeed - 19 Jul 2006
Par Pharmaceutical Receives Final Approval to Market Meloxicam Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 19 Jul 2006
Endo Pharmaceuticals and Vernalis plc Announce the Filing of the Supplemental NDA for Frova(R) for Short-Term Prevention of Menstrual Migraine
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Jul 2006
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Mobic(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 19 Jul 2006
Abbott Announces FDA Clearance of Cell-Dyn Ruby(TM) Hematology Instrument
Diagnostics FDA

HSMN NewsFeed - 19 Jul 2006
FDA Grants Intracel Special Protocol Assessment (SPA) for Confirmatory, Pivotal Phase III Study of OncoVAX(R) Colon Cancer Vaccine
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jul 2006
FDA Grants Review of Issues Pertaining to Cardima's REVELATION(R) Tx PMA
Devices Cardiology FDA

HSMN NewsFeed - 18 Jul 2006
Abbott Announces Approval of First Fully-Automated Blood Screening Tests for Hepatitis B Surface Antigen
Diagnostics FDA

HSMN NewsFeed - 18 Jul 2006
Smith & Nephew Receives FDA Approval for EXOGEN 4000+(TM) Bone Healing System
Devices Orthopaedic FDA

HSMN NewsFeed - 18 Jul 2006
St. Jude Medical Announces FDA Approval of Atlas II ICD and Atlas II Heart Failure Devices
Devices Cardiology FDA

HSMN NewsFeed - 18 Jul 2006
Cyberonics Receives FDA Real-Time Review Approval for New VNS Therapy Perennia Lead
Devices FDA

HSMN NewsFeed - 18 Jul 2006
AstraZeneca Submits NDA for Sustained Release Formulation of SEROQUEL(R) for Schizophrenia Treatment
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Jul 2006
MedImmune Receives Complete Response Letter From FDA for New Formulation of FluMist(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Jul 2006
Alphatec Holdings, Inc. Announces FDA Clearance for Its Adjustable Bridge Product
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 18 Jul 2006
FDA Approves IMPLANON(TM) (etonogestrel implant) 68mg, the First and Only Single-Rod Implantable Contraceptive
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 17 Jul 2006
Innovasis Announces Successful FDA Clearance for Opteryx Cervical Plate System
Devices FDA Orthopaedic Neurosurgery

HSMN NewsFeed - 17 Jul 2006
Cambrex and Ortec Submit to FDA a Humanitarian Device Exemption (HDE) for OrCel(R) to Treat Epidermolysis Bullosa Patients
Devices

HSMN NewsFeed - 17 Jul 2006
OrthoHelix(TM) Surgical Design, Inc. Receives Clearance from FDA for Calcaneal Trauma System
Devices FDA

HSMN NewsFeed - 17 Jul 2006
FDA Approves Lilly's Gemzar(R) For Ovarian Cancer Treatment
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Jul 2006
WaveLight's ALLEGRETTO WAVE(R) Eye-Q Receives FDA Clearance
Devices Ophthalmology

HSMN NewsFeed - 17 Jul 2006
Medtronic Receives FDA Approval for Guardian(R) REAL-Time Continuous Glucose Monitoring System
Devices Endocrinology FDA

HSMN NewsFeed - 17 Jul 2006
Wyeth and Progenics Announce Methylnaltrexone Receives FDA Fast Track Designation for Treatment of Postoperative Ileus
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Jul 2006
Nuvo's Pennsaid NDA Resubmission Accepted for Review by U.S. FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Jul 2006
Nabi Biopharmaceuticals Receives Positive Opinion from FDA Blood Products Advisory Committee for Nabi-HB(TM) Intravenous
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Jul 2006
Mylan Announces Tentative Approval for Amlodipine Besylate and Benazepril Hydrochloride Capsules
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 13 Jul 2006
Milestone Scientific Receives 510(k) Premarket Notification Acceptance From FDA for CompuFlo(TM) Computer Controlled Infusion Pump
Devices FDA

HSMN NewsFeed - 13 Jul 2006
Corautus Genetics Announces Partial Lifting of FDA Clinical Hold and Update on GENASIS Database Lock
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 13 Jul 2006
CoGenesys Receives FDA Clearance to Commence Clinical Trials of Cardeva in Patients with Chronic Heart Failure
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 13 Jul 2006
BIOLASE Announces FDA Clearance of Its OCULASE MD(TM) Laser System for Ophthalmology
Devices Ophthalmology FDA

HSMN NewsFeed - 13 Jul 2006
Nastech Pharmaceutical Company Receives FDA Communication Concerning Calcitonin-Salmon Nasal Spray
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 13 Jul 2006
Biosite(R) Announces FDA Clearance to Market Triage(R) TOX Drug Screen
Diagnostics FDA

HSMN NewsFeed - 13 Jul 2006
Elekta Recieves U.S. Regulatory Approval for Treatment Planning on Leksell Gamma Knife(R) Perfexion(TM)
Devices Oncology FDA

HSMN NewsFeed - 12 Jul 2006
Teva Announces Tentative Approval of Generic Lotrel(R) Capsules
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 12 Jul 2006
Kensey Nash Receives FDA 510(k) Clearance for TriActiv FX(R) Embolic Protection System
Devices Interventional Cardiology FDA

HSMN NewsFeed - 12 Jul 2006
U.S. Food and Drug Administration (FDA) Approves ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), The First Once-Daily Single Tablet Regimen for Adults with HIV-1 Infection
Biopharmaceuticals FDA HIV/AIDS

HSMN NewsFeed - 12 Jul 2006
Cyberonics Receives FDA Approval for Harmonized/Modularized VNS Therapy System Labeling Format
Devices FDA Neurology

HSMN NewsFeed - 12 Jul 2006
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Glucotrol(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 12 Jul 2006
Kos Submits Supplemental New Drug Application To FDA For New Niaspan(R) CF Range of Products
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 12 Jul 2006
Bovie Medical Corporation Announces the Filing of an FDA 510(K) Application for New GI Device: Anticipates over 30% Growth in Revenue for the Second Quarter
Devices Surgery Gastroenterology FDA

HSMN NewsFeed - 11 Jul 2006
FDA Approves Abiomed's New Integrated Off-Pump Cannula
Devices Cardiology FDA

HSMN NewsFeed - 11 Jul 2006
FDA Approves EMEND(R) (aprepitant), Merck's Antiemetic Therapy, for the Prevention of Postoperative Nausea and Vomiting
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Jul 2006
FDA Approves Fuji's Digital Mammography System for Use in the U.S.
Devices Radiology FDA

HSMN NewsFeed - 11 Jul 2006
GlaxoSmithKline Announces FDA Approval and the Launch of Avandamet(R) (Rosiglitazone Maleate and Metformin HCl) as Initial Therapy in the Treatment of Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 10 Jul 2006
Visiogen's Barbara Niksch to Serve as Industry Representative on the FDA's Ophthalmic Devices Panel of the Medical Devices Advisory Committee
Devices Ophthalmology Personnel

HSMN NewsFeed - 10 Jul 2006
FDA Approves Clinical Trial for Medtronic's DIAM(TM) Spinal Stabilization System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 10 Jul 2006
FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic(R)
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Jul 2006
OMRIX Biopharmaceuticals Receives FDA Approval for Second Generation Fibrin Sealant, Evicel(TM), For Use in Liver Surgery
Devices Surgery FDA

HSMN NewsFeed - 10 Jul 2006
Genoptix Announces FDA Cleared Test to Identify Circulating Tumor Cells
Diagnostics Oncology FDA

HSMN NewsFeed - 10 Jul 2006
US Spine Announces Successful FDA Clearance for the Facet Fixation System
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 7 Jul 2006
PuriCore Announces 510k Approval From FDA for VASHE(TM) Wound Cleansing System
Devices FDA Wound Care

HSMN NewsFeed - 6 Jul 2006
ZARS Pharma Announces FDA Approval of a Topical Local Anesthetic Peel (Lidocaine and Tetracaine) 7%/7%
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 6 Jul 2006
Topspin Medical Gets FDA Approval to Start Clinical Trials in the US and Completes the Development of a Prototype of its Advanced Generation Intravascular MRI (IVMRI) Catheter
Devices Interventional Cardiology

HSMN NewsFeed - 6 Jul 2006
Zimmer Holdings Receives U.S. Regulatory Approval to Begin Sale of Ceramic Hip Replacements
Devices Orthopaedic FDA

HSMN NewsFeed - 6 Jul 2006
MedImmune Receives FDA Approval to Use Reverse Genetics Technology for FluMist(R) Vaccine Production
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Jul 2006
ISTA Pharmaceuticals Files New Drug Application with U.S. Food and Drug Administration for T-Pred(TM), a Tobramycin and Prednisolone Acetate Combination Product
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 6 Jul 2006
FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Jul 2006
Uroplasty, Inc. Announces FDA Clearance for Their Next-Generation Device to Treat Overactive Bladder
Devices Urology Neurology FDA

HSMN NewsFeed - 5 Jul 2006
FDA Clears Lumen Biomedical Catheter for Removing Clots from Arteries
Devices Interventional FDA

HSMN NewsFeed - 5 Jul 2006
Medtronic Receives FDA Approval for InterStim(R) II System for Treatment of Overactive Bladder, Urinary Retention
Devices Neurology Urology FDA

HSMN NewsFeed - 5 Jul 2006
COLAZAL(R) Pediatric Exclusivity Filing Submitted
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 5 Jul 2006
Cook Zilver Stent Receives FDA Approval for Vascular Use
Devices Interventional FDA

HSMN NewsFeed - 30 Jun 2006
FDA Approves LUCENTIS for the Treatment of Wet Age-Related Macular Degeneration
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 30 Jun 2006
EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist(TM) Approvable Letters
Biopharmaceuticals Radiology FDA

HSMN NewsFeed - 30 Jun 2006
Teva Receives FDA Approval for Generic Zoloft(R) Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 30 Jun 2006
Ranbaxy Receives Approval to Market Cefprozil Suspension
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 30 Jun 2006
Par Pharmaceutical Receives Final Approval to Market Tranylcypromine Sulfate Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 29 Jun 2006
The International Myeloma Foundation Says REVLIMID(R) Approval for Multiple Myeloma Can Be Life-Changing for Cancer Patients
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Jun 2006
REVLIMID(R) in Combination With Dexamethasone sNDA Granted Approval By FDA for Treatment of Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 Jun 2006
Cephalon Receives Approvable Letter for FENTORA(TM) (fentanyl buccal tablet) for Management of Breakthrough Pain in Patients with Cancer
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 29 Jun 2006
Baxter and FDA Reach Agreement on Next Steps for U.S. Infusion Pumps
Devices FDA

HSMN NewsFeed - 29 Jun 2006
sanofi-aventis Announces Update to Ketek(R) (Telithromycin) U.S. Prescribing Information
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Jun 2006
FDA Grants Fast Track Designation for TargeGen TG100-115 Cardiovascular Compound
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 29 Jun 2006
InSite Vision Announces Submission of AzaSite(TM) NDA
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 29 Jun 2006
Raymedica(R) Receives FDA Approval to Initiate Patient Enrollment in the HydraFlex(TM) Nucleus Arthroplasty System(TM) Clinical Trial
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 28 Jun 2006
FDA Approves SPRYCEL(TM) (dasatinib) With Two Indications
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Jun 2006
Wyeth Receives Approvable Letter From the FDA for Lybrel
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Jun 2006
Cochlear Receives FDA Approval for the Next Generation of the Nucleus(R) Freedom(TM) Cochlear Implant System
Devices

HSMN NewsFeed - 28 Jun 2006
Oscient Pharmaceuticals Announces Meeting Date for FDA Advisory Committee to Address sNDA for Five-Day Treatment of Acute Bacterial Sinusitis with FACTIVE Tablets
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Jun 2006
EntreMed Granted Orphan Drug Designation for Panzem(R) (2ME2) In Glioblastoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 27 Jun 2006
The U.S. Food and Drug Administration Approves Exelon(R) (rivastigmine tartrate) as the First Medication Indicated to Treat Parkinson's Disease Dementia
Biopharmaceuticals FDA Neurology

HSMN NewsFeed - 27 Jun 2006
GlucoTec, Inc. Receives FDA Clearance to Market GLUCOMMANDER(TM) PLUS Insulin Dosing System
Devices Endocrinology FDA

HSMN NewsFeed - 27 Jun 2006
FDA Approves Abiomed's IDE for IMPELLA 5.0 Minimally Invasive Cardiac Support Systems
Devices Cardiology FDA

HSMN NewsFeed - 26 Jun 2006
ev3 Receives FDA Clearance for SpideRX(TM) Embolic Protection Device for Saphenous Vein Graft Angioplasty
Devices Interventional FDA

HSMN NewsFeed - 26 Jun 2006
Stryker Submits Application to FDA For Spinal Indication For OP-1 Putty
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 26 Jun 2006
Lupin Receives Final Approval for Quinapril Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 26 Jun 2006
Abbott Receives FDA Approval for New HUMIRA(R) Delivery Device
Biopharmaceuticals FDA Drug Delivery

HSMN NewsFeed - 26 Jun 2006
Antares Reports On End of Phase II Meeting with FDA for Anturol(TM)
Biopharmaceuticals Urology

HSMN NewsFeed - 23 Jun 2006
Ranbaxy Receives FDA Approval to Market Simvastatin 80mg Tablets with 180-Day Exclusivity
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 23 Jun 2006
Teva Receives First U.S. Approval of Generic Zocor(R) Tablets
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 23 Jun 2006
Allergan Announces FDA Approval of LUMIGAN(R) as First-Line Treatment for Elevated Eye Pressure in Open-Angle Glaucoma
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 23 Jun 2006
Penwest Announces That Endo Reports Receiving Final FDA Approval for Oxymorphone ER
Biopharmaceuticals

HSMN NewsFeed - 23 Jun 2006
Teva Announces Novartis' Sandoz Unit Seeks to Delay First FDA Approval of Generic Zocor(R)
Biopharmaceuticals Generics Litigation

HSMN NewsFeed - 23 Jun 2006
Endo Receives FDA Approval for Opana(R) ER (oxymorphone HCl) Extended-Release and Opana(R) (oxymorphone HCl) Immediate Release Tablets CII
Biopharmaceuticals FDA

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