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Healthcare News Roundup: FDA

 HSMN NewsFeed - 29 Jan 2009
FDA Accepts Eurand's Response to Approvable Letter for EUR-1008 as Complete
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Jan 2009
FDA Provides Clear Path to NDA Submission for Pro-Pharmaceuticals’ DAVANAT(R)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 29 Jan 2009
POZEN Informed by FDA That Endoscopic Gastric Ulcer Incidence Continues to Be an Acceptable Primary Endpoint
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Jan 2009
Mylan Receives Final FDA Approvals for Generic Versions of Lamictal(R) Tablets and Lamictal(R) CD
Biopharmaceuticals Generics Neurology FDA
 HSMN NewsFeed - 27 Jan 2009
Watson's GELNIQUE(TM) (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder
Biopharmaceuticals Drug Delivery Urology FDA
 HSMN NewsFeed - 27 Jan 2009
Oxygen Biotherapeutics, Inc. Submits Request for Designation to FDA for Oxycyte(R)-based Wound Care Product
Devices Wound Care FDA
 HSMN NewsFeed - 27 Jan 2009
First product from collaboration between RaySearch and TomoTherapy receives FDA clearance
Devices Oncology FDA
 HSMN NewsFeed - 27 Jan 2009
Pixantrone Pre-NDA Communication from FDA Provides Cell Therapeutics Basis to Begin Rolling NDA Submission
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 26 Jan 2009
Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 23 Jan 2009
IMPAX Receives Final FDA Approval for Omeprazole 40 mg Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 23 Jan 2009
CLX Medical, Inc. Issues CEO Comment on Status of Company With Ownership and Planned Distribution of FDA Cleared ThyroTest(R) Product
Diagnostics Distribution
 HSMN NewsFeed - 23 Jan 2009
Mylan Receives Final FDA Approval for Generic Version of Prilosec(R) Delayed-Release Capsules, 40 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 23 Jan 2009
Geron Receives FDA Clearance to Begin World's First Human Clinical Trial of Embryonic Stem Cell-Based Therapy
Regenerative Medicine Neurosurgery FDA
 HSMN NewsFeed - 20 Jan 2009
Astro-Med's Grass Technologies Group Receives FDA Clearance to Market Its Neurotrac(R) III Neuromonitoring System
Devices Monitoring Neurology FDA
 HSMN NewsFeed - 20 Jan 2009
STERIS Corporation Submits New Sterilization System To FDA and Announces Developments on SYSTEM 1 Warning Letter
Devices FDA
 HSMN NewsFeed - 20 Jan 2009
FDA Issues Complete Response Letter to SCOLR Pharma's Abbreviated New Drug Application for CDT(R) 12-Hour Pseudoephedrine
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 19 Jan 2009
FDA Issues Complete Response Letter for Iclaprim
Biopharmaceuticalas FDA
 HSMN NewsFeed - 19 Jan 2009
Abbott Receives FDA CLIA Waiver for Use of Five Additional Cartridges on the i-STAT Handheld Blood Analyzer
Devices Diagnostics
 HSMN NewsFeed - 17 Jan 2009
Pfizer Receives FDA Complete Response Letter for Lasofoxifene
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Jan 2009
Advanced Medical Optics Receives FDA Approval for TECNIS(R) Multifocal Intraocular Lens
Devices Ophthalmology FDA
 HSMN NewsFeed - 17 Jan 2009
CSL Behring Receives FDA Approval of RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Jan 2009
Lupin is Granted USFDA Approval for Levetiracetam Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 15 Jan 2009
Osiris Receives FDA Clearance to Broaden Prochymal Expanded Access Program
Regenerative Medicine FDA
 HSMN NewsFeed - 15 Jan 2009
Osiris and FDA Reach Agreement on Submission of First Marketing Application for a Stem Cell Product
Regenerative Medicine FDA
 HSMN NewsFeed - 14 Jan 2009
U.S. FDA Issues Complete Response Letter for SAPHRIS(TM) (ASENAPINE) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder
Biopharmaceuticals
 HSMN NewsFeed - 12 Jan 2009
BD Announces FDA 510(k) Clearance of Novel Molecular Assay to Diagnose Clostridium difficile Infections
Diagnostics FDA
 HSMN NewsFeed - 9 Jan 2009
Anesiva Announces FDA Approval of Supplemental New Drug Application to Expand Zingo(TM) Indication
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 8 Jan 2009
FDA Advisory Committee Unanimously Recommends Sabril(R) (vigabatrin) for the Treatment of Two Catastrophic Epilepsies
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 8 Jan 2009
American Medical Systems Announces FDA Clearance for Elevate(R) Anterior and Apical Prolapse Repair System
Devices FDA
 HSMN NewsFeed - 8 Jan 2009
Covidien Receives FDA Clearance to Market SILS(TM) Port Multiple Instrument Access Port
Devices Surgery FDA
 HSMN NewsFeed - 8 Jan 2009
Medegen Receives FDA Clearance for MaxGuard(TM) Advanced Luer-Activated Device with Antimicrobial Technology
Devices FDA
 HSMN NewsFeed - 8 Jan 2009
Meridian Receives FDA Approval
Devices FDA
 HSMN NewsFeed - 7 Jan 2009
Nomir Medical Announces Second FDA 510(k) Clearance of its Noveon(R) Dual-Wavelength Device
Devices FDA
 HSMN NewsFeed - 5 Jan 2009
Prism Pharmaceuticals Receives FDA Approval of NEXTERONE(R) for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia
Biopharmaceuticals Cardiology
 HSMN NewsFeed - 3 Jan 2009
EZ Surgical Receives FDA 510k Clearance for Surgical Devices
Devices Surgery FDA
 HSMN NewsFeed - 2 Jan 2009
FDA Announces Class I Recall of Ophthalmic Surgical Device
Devices Ophthalmology Surgery FDA Product Recall
 HSMN NewsFeed - 31 Dec 2008
FDA Cardio Renal Advisory Committee to Review Daiichi Sankyo, Lilly Drug Prasugrel
Biopharmaceuticals Cardiology
 HSMN NewsFeed - 31 Dec 2008
Labopharm Announces FDA Approval of Once-Daily RYZOLT(TM) (Tramadol HCL Extended Release Tablets) for Management of Moderate to Moderately Severe Chronic Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 Dec 2008
FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C
Diagnostics FDA
 HSMN NewsFeed - 30 Dec 2008
U.S. Navy Requested Operations Trial on FDA Hold
Biopharmaceuticals
 HSMN NewsFeed - 30 Dec 2008
Mylan's Matrix Receives Final FDA Approval for the Generic Version of the Antiretroviral Zerit(R) Capsules
Biopharmaceuticals Generics FDA HIV/AIDS
 HSMN NewsFeed - 29 Dec 2008
Watson Pharmaceuticals Receives FDA Final Approval for Generic Mircette(R)
Biopharmaceuticals FDA Generics
 HSMN NewsFeed - 29 Dec 2008
Salix Receives FDA Complete Response Letter for Balsalazide Tablet
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 29 Dec 2008
Perrigo Announces FDA Final Approval for Ibuprofen PM
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 23 Dec 2008
Beckman Coulter Announces FDA Clearance of UniCel(R) DxH 800
Devices Diagnostics FDA
 HSMN NewsFeed - 22 Dec 2008
EPIX Pharmaceuticals Announces FDA Approval of Vasovist(R) (gadofosveset trisodium)
Biopharmaceuticals Radiology
 HSMN NewsFeed - 19 Dec 2008
Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer
Biopharmaceuticals
 HSMN NewsFeed - 19 Dec 2008
Antisoma receives FDA approval for oral fludarabine, plans commercialisation deal to bring drug to US patients
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Dec 2008
EDAP Submits 510(k) Filing to U.S. FDA for Sonolith I-Sys
Devices Urology FDA
 HSMN NewsFeed - 18 Dec 2008
StemCells, Inc. Receives FDA Approval To Initiate Clinical Trial Of HuCNS-SC® Cells In A Myelin Disease
Regenerative Medicine Neurology
 HSMN NewsFeed - 16 Dec 2008
Watson Pharmaceuticals Receives FDA Approval for Generic Razadyne(R) ER Capsules
Biopharmaceuticals Generics Neurology FDA
 HSMN NewsFeed - 16 Dec 2008
CeloNova BioSciences Receives FDA Market Approval for Embozene(TM) Color-Advanced Microspheres Embolization Platform
Devices Interventional FDA
 HSMN NewsFeed - 15 Dec 2008
FDA Approves Genzyme's Mozobil
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Dec 2008
Abbott Receives FDA Approval for TRILIPIX(TM) (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Dec 2008
FDA Approves Boston Scientific's Express(R) SD Renal Stent System
Devices Interventional FDA
 HSMN NewsFeed - 14 Dec 2008
FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Dec 2008
GlaxoSmithKline Statement on FDA Advisory Committee Vote on Use of Asthma Medicines Containing Long-Acting Beta-Agonists
Biopharmaceuticals
 HSMN NewsFeed - 9 Dec 2008
ev3 Inc. Receives FDA Clearance to Market EverCross and NanoCross Peripheral Angioplasty Balloons
Devices Interventional FDA
 HSMN NewsFeed - 5 Dec 2008
FDA Advisory Committee Recommends Approval of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop
Biopharmaceuticals Ophthalmology FDA
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