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News by month %2 2004
News by month October 2004
PTCommunity News October 2004
New Drug Application for Pioglitazone, Metformin Combination Submitted
Generic Celexa Receives FDA Approval
Oral Solution of Levofloxacin Approved
Generic Depo-Provera Granted Final Approval by FDA
Study: Moxifloxacin Highly Successful in Treating Pneumonia in Elderly Patients
Phase 3 Clinical Trial Initiated for RhIGF-1, Treatment for Primary IGF-1 Deficiency
FDA Grants Orphan Drug Designation to BAY 43-9006 for the Treatment of Renal Cell Carcinoma
Amiodarone Hydrochloride Approved
FDA Approves Lanthanum Carbonate To Reduce Phosphate Levels in End-Stage Renal Disease Patients
Notification Letter Sent to Health Care Professionals About Medication Errors Between Reminyl and Amaryl
Approvable Letter Issued for Ciclesonide, Treatment of Persistent Asthma
FDA Approves Clindamycin Foam for Treating Acne
Velac NDA Accepted for Filing by the FDA
Genetics Play Role in Response to Most Common Asthma Drug
Tipranavir New Drug Application Submitted to FDA
Positive Phase 2 Data for BAY 43-9006 in Patients With Advanced Kidney Cancer Announced
Approvable Letter for Thalomid Issued
High Dose Gabapentin Gains Approval
Orally Disintegrating Tablet Version of Donepezil Gains FDA Nod
Pegaptanib Study Shows Benefits in Age-Related Macular Degeneration Are Sustained for Two Years
FluMist Production Expanded
Long-Term Study Demonstrates Adderall Is An Effective Option To Treat Adolescents With ADHD
Choosing Bacteria-Killing vs. Bacteria-Inhibiting Drugs in Treating Infections
Analog of Geldanamycin Granted Orphan Drug Status
Second Phase 3 Trial of Mifepristone in Psychotic Major Depression Initiated
Duloxetine Study Shows Pain Reduction in Fibromyalgia
Abatacept Demonstrates Clinical Activity in Patients With Rheumatoid Arthritis
Pfizer Will Sponsor Major Celecoxib Clinical Trial
79 Percent of Patient Subset Show No Joint Erosion in Infliximab Trial
Weathering the Influenza Vaccine Crisis
Study Suggests Mycophenolate Mofetil Is Effective for Managing Systemic Lupus Erythematosus
FDA Approves Luveris for Concomitant Use With Gonal-f
Approvable Letter Issued for Abetimus Sodium, Lupus Treatment
Infliximab Gains European Approval, Indicated for Psoriatic Arthritis
FDA Strengthens Safeguards for Children Treated With Antidepressant Medications
FDA, U.K. Medicines and Healthcare Products Regulatory Agency Working Collaboratively To Address Flu Vaccine Manufacturing Problems
Anecortave Acetate Fails To Meet Primary Non-Inferiority Endpoint in Wet Age-Related Macular Degeneration Trial
FDA, Centocor Issue Alert for Revisions to Remicade Label
Phase 3 Trial of Cerovive To Continue After Interim Data Analysis
FDA Approves Hylaform Plus
Cellgesic Granted Priority Approval
Flumazenil Injection Cleared by FDA
AGIX-4207 Phase 2 Study in Rheumatoid Arthritis Does Not Meet Primary Endpoint
<i>Staphylococcus Aureus</i> Vaccine Given Fast Track Designation
B-Type Natriuretic Peptide Testing Useful for Diagnosing Heart Failure
Rituximab Label Revised To Include Hepatitis B Virus Warning
FDA Approves First Prefilled, Multi-Dose, Disposable Growth Hormone Delivery System
Positive Results Reported From Phase 2 Dosage Regimen Study for Cetrorelix
FDA Halts TNFerade Clinical Trials
Yondelis Granted Orphan Drug Status, Potential Treatment for Soft Tissue Sarcoma
Two Docetaxel Studies Featured in New England Journal of Medicine
Pegasys-Copegus Combination Granted Fast Track Review for Treatment of Hepatitis C in HIV Patients
Orphan Drug Status Conferred on CoFactor, Adjunct Treatment for Pancreatic Cancer
Antitumour Agent Aplidin Granted Orphan Drug Status
MDX-060 Receives Orphan Drug Designation for Treatment of Hodgkin's Disease
CDC Issues Interim Influenza Vaccination Recommendations
New Drug Application Submitted for Entecavir
FDA Grants Fast Track Status to Squalamine in Macular Degeneration
30 Million Doses of Influenza Vaccine Shipped to Health Care Providers
Study Shows Once-Monthly Ibandronate Increases Bone Density, Reduces Bone Breakdown
Immediate-Release Formulation of Omeprazole Launched
Positive Results Announced From Phase 2 Trial of Telcyta in Combination With Doxil
Study: Investigational Therapy AMG 162 Increased Bone Mineral Density