Newsroom - Speeches Home | Search | Contact - - - Products | R&D | News | About | Careers | Investors - News Corporate News Product News Financial News Other News News Release Archive Speeches Milestones Media Relations - For additional navigation you must have JavaScript enabled.Xigris Named 'Best New Medicine' in 2001 by Med Ad News Xigris®, approved for the treatment of...
BioPortfolio Client Press Releases Site Map FDA to Initiate Study of HEMOLINK in Orthopedic Surgery Mediatum - Management Boutique at the Interface between Pharmaceutical and Biotech Industry Biotech Tracker News - Study Supports BioBypass Development Biotech Tracker News - Onyx’s Raf Inhibitor Shows Promise Biotech Tracker News - Boston Scientific Presents Additional Coated Stent Data Biotech Tracker News - Treatment...
New Topics Infectious Disease Amplicor HIV-1 Monitor Ultrasensitive Test for HIV Viral Loads Ciprofloxacin (Cipro) for the Treatment of Inhalational Anthrax Drotrecogin Alfa (Xigris) for Sepsis With Multi-Organ Failure Effectiveness and Potential Side-Effects of the Anthrax Vaccine Effect of Stress on HIV Disease Progression Environmental Screening and Patient Diagnosis of...
Medicare Drug Reimbursement Primer Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Prescription Drug User Fee Act - User Fee Billable Therapeutic Products: Approved Under Section 351 of the PHS Act IU/mL Corixa Corp License 1614 Bexxar Tositumomab and Iodine I-131 Tositumomab 125011/0 6/27/2003 Therapeutic Regimen Cytogen Corp License 1164 ProstaScint Capromab Pendetide 103608/0 10/28/1996 0.5 mg/mL Elan Pharmaceuticals License 1579 MYOBLOC Botulinum Toxin Type B 103846/0 12/8/2000 5,000 IU/mL Eli Lilly & Company License 1611 Xigris Drotrecogin alfa (...
Drotrecogin alfa (activated), CMC Review, approval 11/21/01 page 8
author: CBER FDA
subject: dob062003
Drotrecogin alfa (activated), CMC Review, approval 11/21/01 page 1
author: CBER FDA
subject: dob062003
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly)- - Product Approval Information - Licensing FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER Product Approval Information - Licensing Action - - To: BLA STN 125029 From: Gary Kikuchi Through: Gibbes Johnson, DTP, Elizabeth Shores, DTP, Barry Cherney, Deputy Director DTP, Amy Rosenberg, Director DTP Date: November 20, 2001 Immunogenicity Review of Xigris, Activated Protein C (...
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis To: BLA STN 125029 From: Gary Kikuchi Through: Gibbes Johnson, DTP, Elizabeth Shores, DTP, Barry Cherney, Deputy Director DTP, Amy Rosenberg, Director DTP Date: November 20, 2001 Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis IXigris, or Activated ...
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 23
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 22
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 21
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 20
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 19
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 18
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 17
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 16
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 15
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 14
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 13
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 12
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 11
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 10
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 8
author: FDA/CBER
Immunogenicity Review of Xigris, Activated Protein C (Drotrecogin alfa, Lilly) for treatment of sepsis page 7
author: FDA/CBER
