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Healthcare News Roundup: FDA

 HSMN NewsFeed - 3 Jan 2008
Escalon(R) Announces FDA 510(k) Clearance for Sonomed MASTER-VU(TM) B-Scan System
Devices Ophthalmology FDA
 HSMN NewsFeed - 3 Jan 2008
FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Jan 2008
Teva Announces Approval of Generic Kytril(R) Injection and Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 3 Jan 2008
DOR BioPharma Receives Orphan Drug Designation for Oral BDP for the Treatment of Pediatric Crohn's Disease
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 3 Jan 2008
EntreMed Announces FDA Acceptance of IND Application for Aurora Kinase/Angiogenesis Inhibitor, ENMD-2076
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 2 Jan 2008
Sciele Pharma Announces FDA Approval of New Sular(R) Formulation
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 2 Jan 2008
Teva Announces Approval of Generic DuoNeb
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 2 Jan 2008
FDA Marketing Clearance for the "Vicorder" New Portable Device to Detect Peripheral Vascular Disease
Devices FDA
 HSMN NewsFeed - 2 Jan 2008
Barr Receives Approval for Generic KYTRIL(R) Tablets, 1mg (Base)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 2 Jan 2008
BD Announces FDA 510(k) Clearance of Two-Hour Test to Identify Superbug in Patients with Positive Blood Cultures
Diagnostics FDA
 HSMN NewsFeed - 2 Jan 2008
Varian Medical Systems Receives FDA 510(k) Clearance for RapidArc(TM) Radiotherapy Technology
Devices Oncology FDA
 HSMN NewsFeed - 2 Jan 2008
Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza
Biopharmaceuticals FDA Endocrinology Drug Delivery
 HSMN NewsFeed - 31 Dec 2007
Cephalon Submits New Drug Application for TREANDA for the Treatment of Patients with Relapsed Indolent Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 31 Dec 2007
Salix Pharmaceuticals Announces Submission of Granulated Mesalamine New Drug Application
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 31 Dec 2007
Mylan Announces Final FDA Approval for Balsalazide Disodium Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 31 Dec 2007
Forest and Cypress Announce Submission of New Drug Application for Milnacipran for the Treatment of Fibromyalgia Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Dec 2007
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Zyrtec Allergy Tablets(R) and Zyrtec Hives Relief Tablets(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 28 Dec 2007
Perrigo Announces FDA Approval for Over-The-Counter Cetirizine Hydrochloride Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 28 Dec 2007
Mylan Announces Final FDA Approval for Cetirizine Hydrochloride Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 27 Dec 2007
Theravance Receives Notice of Possible Telavancin Review by FDA Advisory Committee
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Dec 2007
Noven Announces FDA Tentative Approval of Stavzor(TM) Valproic Acid Delayed Release Capsules
Biopharmaceuticals FDA
 HSMN NewsFeed - 26 Dec 2007
Hitachi Receives FDA Clearance for Spot Scanning of PROBEAT Proton Beam Therapy System
Devices Oncology FDA
 HSMN NewsFeed - 24 Dec 2007
Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Dec 2007
Pharmacyclics Receives Non-Approvable Letter from the FDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 21 Dec 2007
FDA Issues Approvable Letter for 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 - 21 Dec 2007
Pfizer Receives Approvable Letter from FDA for Dalbavancin
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Dec 2007
Supplemental New Drug Application for PREZISTA(TM) Submitted to U.S. Food and Drug Administration
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 21 Dec 2007
Power Medical Interventions, Inc. Receives FDA 510(k) Marketing Clearance for iDrive Intelligent Surgical Instruments
Devices Surgery FDA
 HSMN NewsFeed - 21 Dec 2007
Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multiple Myeloma
Biopharmaceuticals FDA Oncology
 HSMN NewsFeed - 21 Dec 2007
Akorn, Inc. Announces FDA Inspection Results
Biopharmaceuticals
 HSMN NewsFeed - 20 Dec 2007
GlaxoSmithKline Files for FDA Approval of PROMACTA(TM) (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Dec 2007
Abiomed Receives FDA Approval for the Combination iPulse(TM) Circulatory Support System
Devices Cardiology FDA
 HSMN NewsFeed - 18 Dec 2007
FDA Approves New Mechanism of Action Labeling for Ranexa(R)
Biopharmaceuticals. Cardiology FDA
 HSMN NewsFeed - 18 Dec 2007
Escalon(R) Announces FDA 510(K) Clearance for D3 Hematology System
Diagnostics FDA
 HSMN NewsFeed - 18 Dec 2007
Anthera's A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Dec 2007
FDA Approves Celltrion to Manufacture ORENCIA(R) (abatacept)
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Dec 2007
Bystolic(TM), a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 18 Dec 2007
ATS Medical Receives FDA Approval for AP360 Mechanical Heart Valve
Devices Cardiology FDA
 HSMN NewsFeed - 18 Dec 2007
RaySearch Laboratories: COMPASS(R) Receives FDA Clearance and is Launched
Devices Radiology FDA
 HSMN NewsFeed - 17 Dec 2007
Angiotech Submits 510(K) To FDA For Its Innovative 5-FU CVC
Devices
 HSMN NewsFeed - 17 Dec 2007
Baxter Announces FDA Approval of GELFOAM(R) Plus Hemostasis Kit
Biopharmaceuticals Devices Surgery FDA
 HSMN NewsFeed - 17 Dec 2007
Genzyme Announces FDA Approval of Thyrogen(R) for Use in Thyroid Cancer Ablation
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 17 Dec 2007
PARI Hydrate Receives FDA Clearance
Devices FDA
 HSMN NewsFeed - 17 Dec 2007
GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervical Cancer Vaccine
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 14 Dec 2007
Eclipse(TM) Proton Scanning Algorithm from Varian Medical Systems Receives FDA Clearance
Devices Oncology FDA
 HSMN NewsFeed - 13 Dec 2007
FDA Advisory Panel Finds Hologic's Adiana(R) Permanent Contraception Approvable
Devices FDA
 HSMN NewsFeed - 13 Dec 2007
FDA Advisory Panel Recommends Against Approval of Merck's NDA for Non-prescription MEVACOR(R) (lovastatin) 20 mg
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 13 Dec 2007
BioMarin Announces FDA Approval for Kuvan
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Dec 2007
Neurologix Gene Therapy Approach to Parkinson's Disease Granted Fast Track Designation From FDA
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 13 Dec 2007
Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Dec 2007
Neupro(R) Filed with the FDA for the Treatment of Advanced-Stage Parkinson's Disease
Biopharmaceuticals Neurology
 HSMN NewsFeed - 13 Dec 2007
Neupro(R) Filed with the FDA for the Treatment of Restless Legs Syndrome
Biopharmaceuticals Neurology
 HSMN NewsFeed - 12 Dec 2007
Agendia's MammaPrint(R), the Only FDA-Cleared Breast Cancer Prognosis Test, is Now Widely Available to U.S. Patients
Diagnostics Oncology FDA
 HSMN NewsFeed - 12 Dec 2007
Teva Announces Approval of Generic Trileptal(R) Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 12 Dec 2007
Lannett Receives FDA Approval for Phentermine
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 12 Dec 2007
Cytori Therapeutics Receives FDA 510(k) Clearance for the Cytori Fat Transfer System
Devices Surgery FDA
 HSMN NewsFeed - 11 Dec 2007
FDA Advisory Committee Recommends Approval of KYNAPID(TM) for Acute Atrial Fibrillation
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 11 Dec 2007
Zimmer Holdings Receives FDA Approval to Market Mobile Bearing Knee
Devices FDA Orthopaedic
 HSMN NewsFeed - 11 Dec 2007
EntreMed Announces FDA Acceptance of IND Application for Panzem(R) in Rheumatoid Arthritis
Biopharmaceuticals
 HSMN NewsFeed - 11 Dec 2007
Amedica Receives FDA Special 510(k) Clearance for its Valeo(TM) Ceramic Spinal Implant
Devices FDA Orthopaedic Neurosurgery
 HSMN NewsFeed - 11 Dec 2007
Cyberkinetics Receives FDA Response Letter on Andara(TM) OFS(TM) System for Acute Spinal Cord Injury
Devices Neurology
 HSMN NewsFeed - 11 Dec 2007
Sysmex America Receives FDA Clearance for XE-5000(TM) Hematology Analyzer
Diagnostics FDA
 HSMN NewsFeed - 10 Dec 2007
FDA Concludes There is No Increased Risk of Cardiac Events for Patients Treated with omeprazole and NEXIUM(R) (esomeprazole magnesium)
Biopharmaceuticals
 HSMN NewsFeed - 10 Dec 2007
BMEYE(TM) Announces FDA 510(K) Clearance for Nexfin(TM)
Devices Monitoring FDA
 HSMN NewsFeed - 10 Dec 2007
GTC Obtains FDA Orphan Drug Designation For ATryn(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Dec 2007
Celldex Therapeutics Announces Orphan Drug Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma Multiforme
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 7 Dec 2007
Vidacare(R) Announces Clearance of Novel Bone Marrow Biopsy System for Hematology/Oncology
Devices FDA
 HSMN NewsFeed - 7 Dec 2007
FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa(R)
Biopharmaceuticals Cardiology
 HSMN NewsFeed - 7 Dec 2007
DOR BioPharma Announces Results of orBec(R) End of Review Conference With the FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 7 Dec 2007
Amgen in Discussions with FDA to Update U.S. Prescribing Information for ESAs
Biopharmaceuticals
 HSMN NewsFeed - 6 Dec 2007
Onset Therapeutics Announces FDA Submission for Novel Product for Topical Treatment of Genital Warts
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 5 Dec 2007
Genentech Provides Update from Avastin FDA Advisory Meeting
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 Dec 2007
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Norvasc(R)
Biopharmaceuticals FDA Generics
 HSMN NewsFeed - 4 Dec 2007
Mylan Announces Tentative FDA Approval Under PEPFAR for Tenofovir Disoproxil Fumarate Tablets
Biopharmaceuticals HIV/AIDS Generics FDA
 HSMN NewsFeed - 4 Dec 2007
Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis
Biopharmaceuticals FDA Regulatory
 HSMN NewsFeed - 4 Dec 2007
Reliant Technologies Receives Industry's Only FDA 510(K) Clearance for a Fractional Ablative Resurfacing Device
Devices Dermatology FDA
 HSMN NewsFeed - 3 Dec 2007
FDA Approves Diovan(R) for Treatment of High Blood Pressure in Children
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Dec 2007
Medtronic Files PMA Application for FDA Approval of Talent(TM) Abdominal Stent Graft System
Devices Interventional FDA
 HSMN NewsFeed - 3 Dec 2007
Immunicon Corporation Announced the Filing for FDA Clearance of the CellSearch(TM) Circulating Tumor Cell Kit for Monitoring Patients with Metastatic Androgen-Independent Prostate Cancer
Diagnostics Oncology
 HSMN NewsFeed - 2 Dec 2007
FDA Issues Approvable Letter for Nebivolol for the Treatment of Hypertension
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Nov 2007
Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lexapro(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 30 Nov 2007
FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 Nov 2007
Teva Announces Tentative Approval of Generic Requip(R) Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 29 Nov 2007
Boston Scientific Welcomes FDA Panel Recommendation to Approve PROMUS(TM) / XIENCE(TM) V Everolimus-eluting Coronary Stent System
Devices Interventional Cardiology
 HSMN NewsFeed - 29 Nov 2007
FDA Advisory Committee Recommends Approval of Abbott's XIENCE(TM) V Drug Eluting Stent System
Devices Interventional Cardiology
 HSMN NewsFeed - 29 Nov 2007
Amneal Receives FDA Approval for Bethanechol Chloride Tablets, USP Using New Expedited FDA Approval Process
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 29 Nov 2007
UCB Announces FDA Filing for lacosamide in the Treatment of Diabetic Neuropathic Pain
Biopharmaceuticals
 HSMN NewsFeed - 29 Nov 2007
UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures in Adults with Epilepsy
Biopharmaceuticals Neurology
 HSMN NewsFeed - 28 Nov 2007
Adolor and GlaxoSmithKline Announce FDA Advisory Committee to Review Entereg(R) (alvimopan) for the Management of Postoperative Ileus (POI)
Biopharmaceuticals Surgery
 HSMN NewsFeed - 28 Nov 2007
Merit Medical Announces 510(k) Notification for Two Additional Products
Devices FDA
 HSMN NewsFeed - 27 Nov 2007
Abbott to Present Comprehensive Safety and Efficacy Data on XIENCE(TM) V Drug Eluting Stent to FDA Advisory Committee on Nov. 29
Devices Interventional Cardiology
 HSMN NewsFeed - 27 Nov 2007
Watson Receives FDA Approval For Generic Combunox(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 27 Nov 2007
Toshiba's AquilionONE Receives FDA Clearance
Devices Radiology FDA
 HSMN NewsFeed - 26 Nov 2007
Meridian Bioscience Receives FDA Clearance for Two New Rapid Tests for the Detection of Influenza and Respiratory Syncytial Virus
Diagnostics FDA
 HSMN NewsFeed - 26 Nov 2007
Alara Receives FDA Clearance to Market CRystalView T-Series CR system
Devices Radiology FDA
 HSMN NewsFeed - 26 Nov 2007
Amedica Receives FDA 510(k) Clearance for Valeo(TM) Pedicle Screw System
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 26 Nov 2007
Merit Medical Announces 510(k) Notification for Resolve Biliary Catheter
Devices Interventional FDA
 HSMN NewsFeed - 26 Nov 2007
St. Jude Medical Announces FDA Approval of Epic Stented Tissue Valve with Anti-Calcification Technology
Devices Cardiology FDA
 HSMN NewsFeed - 26 Nov 2007
CellSearch(TM) Circulating Tumor Cell Kit Receives FDA Clearance for Monitoring Patients with Metastatic Colorectal Cancer
Diagnostics FDA
 HSMN NewsFeed - 21 Nov 2007
Labopharm receives FDA response to appeal of Approvable Letter for once-daily tramadol
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Nov 2007
Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
Biopharmaceuticals
 HSMN NewsFeed - 20 Nov 2007
Spinal Elements, Inc. Receives FDA 510(k) Market Clearance for its Lucent(R) Spinal Implants as a Lumbar Intervertebral Body Fusion Device (IBFD)
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 20 Nov 2007
U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Nov 2007
NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 20 Nov 2007
Delcath Resumes Enrollment in Phase III and Phase II Trials
Devices Drug Delivery Oncology FDA
 HSMN NewsFeed - 20 Nov 2007
EarlySense Receives FDA Clearance for Its Contact-Free Patient's Clinical Status Monitor
Devices Monitoring FDA
 HSMN NewsFeed - 19 Nov 2007
Powerful New Efficacy Data in Moderate and Severe Hypertensive Patients Supports FDA Approval of AVALIDE(R) (Irbesartan-Hydrochlorothiazide) as First Combination Therapy for Initial Use in Patients Likely to Need Multiple Drugs to Achieve BP Goals
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 19 Nov 2007
Nexavar First FDA-Approved Drug Therapy for Liver Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Nov 2007
FDA Approves the Allergy Treatment Zyrtec(R) for Use Without a Prescription
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Nov 2007
DexCom(TM) Receives FDA Approval to Calibrate Its SEVEN(TM) Continuous Glucose Monitoring System Using Any FDA Cleared Blood Glucose Meter
Devices Diagnostics FDA
 HSMN NewsFeed - 16 Nov 2007
SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Nov 2007
Wyeth Receives FDA Approval of Protonix for Delayed-Release Oral Suspension
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 15 Nov 2007
ABILIFY(R) (aripiprazole) Supplemental New Drug Application for the Treatment of Pediatric Patients with Bipolar I Disorder Accepted for Priority Review by the U.S. Food and Drug Administration
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Nov 2007
Medtronic Receives FDA Marketing Clearance For Complete SE Biliary Stent System
Devices Interventional Gastroenterology Oncology FDA
 HSMN NewsFeed - 14 Nov 2007
GSK Revises US Labeling for Avandia(R)
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 14 Nov 2007
Cost-Effective Spinal Discography Device Receives FDA Clearance: Pinyons Medical Technology's PowrSyringe Expands with New Spine Indication
Devices Orthopaedic FDA
 HSMN NewsFeed - 13 Nov 2007
Genzyme Receives FDA Response Letter on Synvisc-One(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Nov 2007
Cardiogenesis Receives FDA Approval for PEARL 5.0 Robotic Hand Piece
Devices Cardiology FDA
 HSMN NewsFeed - 12 Nov 2007
Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 12 Nov 2007
Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lamictal(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 12 Nov 2007
Lexicon Files Investigational New Drug Application for LX2931 as a Potential Treatment for Rheumatoid Arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Nov 2007
FDA Accepts Chelsea Therapeutics' Investigational New Drug Application for Droxidopa
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Nov 2007
Baxter Receives 510(k) Clearance From FDA For V-Link With VitalShield, New Antimicrobial Intravascular Technology
Devices FDA
 HSMN NewsFeed - 9 Nov 2007
CRESTOR(R) Now Indicated to Slow the Progression of Atherosclerosis in Patients With Elevated Cholesterol
Biopharmaceuticals FDA Cardiology
 HSMN NewsFeed - 8 Nov 2007
FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
Biopharmaceuticals FDA Oncology
 HSMN NewsFeed - 8 Nov 2007
FDA 510(k)-Cleared TerraQuant(R) Combines World's Fastest Super Pulsed Laser With Infrared, Visible Red Light and Magnetic Field to Speed Pain Relief
Devices FDA
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