PharmaPendium December 2011 Release

News Date: 
Tue, 06/12/2011

The December content release includes the following updates:
Year-To-Date EMA and FDA statistics:

  • 133,152 new pages
  • 6,809 new documents
  • 228,462 new extracted PK data observations
  • 102,532 new extracted safety data observations
  • 59 new drugs

Addition of CBER biologics content:

  • 9,077 new pages
  • 495 new documents
  • New data on 51 CBER biologics drugs

FDA Approval Packages:

  • 9 new drugs:
    • Brentuximab Vedotin
    • Crizotinib
    • Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate
    • Vemurafenib
    • Diphtheria and Tetanus Toxoids; Acellular Pertussis Adsorbed; Inactivated Poliovirus Vaccine Combined
    • Diphtheria and Tetanus Toxoids; Acellular Pertussis; Poliomyelitis (Inactivated); Haemophilus B Conjugate Vaccine
    • Fibrinogen
    • Smallpox (Vaccinia) Vaccine, Live
    • Typhoid VI Polysaccharide Vaccine
  • 1555 new FDA Approval Documents
  • 32,540 new pages of FDA Approval Documents

Extracted PK data observations:

  • 32,171 new extracted PK data lines

Extracted Safety data observations:

  • 36,502 new extracted safety data lines

Published Toxicity Database:

  • 1,370 new safety records

AERS (post-marketing) reports:

  • 941 new reports

The new totals for PharmaPendium are:

  • 1,538,594 pages of FDA Approval documents (Including FDA Classic Collection)
  • 65,450 documents of FDA Approval documents (Including FDA Classic Collection)
  • 4102 drugs with data in PharmaPendium
  • 1,079,653 extracted safety data lines
  • 1,256,587 extracted PK data lines
  • 4,131,239 AERS (post-marketing) reports
  • 4,691 documents / 82,421 pages of EMA Approval documents
  • 10,175 documents / 417,321 pages of FDA Advisory Committee Meeting documents
  • 10,906 documents / 308,015 pages of FDA Classic Collection

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