September 2009 release

News Date: 
Tue, 01/09/2009

The September release of PharmaPendium contains the following updates:

  • FDA Approval Packages:
    • 5 New Drugs
      • Abobotulinumtoxina
      • Amlodipine; Hydrochlorothiazide; Valsartan
      • Besifloxacin Hydrochloride
      • Iloperidone
      • Tolvaptan
    • 585 New FDA Approval Documents, including documents for 18 new Approval Packages
    • 13,299 New pages of FDA Approval Documents
  • EMEA (Europe) EPAR document database:
    • 6 New Drugs
      • Bazedoxifene acetate
      • Catumaxomab
      • Eslicarbazepine Acetate
      • Influenza Vaccine (Split Virion, Inactivated)
      • Mifamurtide
      • Ulipristal acetate
    • 413 Updated documents (replaced by newer versions)
    • 233 New EMEA Approval Documents
    • 7,912 Increase of pages amount for EMEA due to new files appearance and files update
  • Extracted Safety data observations:
    • 5,412 new extracted data lines for FDA
    • 8,411 Increase of extracted data lines amount for EMEA due to new files appearance and files update
  • AERS (post-marketing) reports
    • 76,463 new reports (2009_Q1 added + additional matching provided)
  • New Totals:
    • 1,283,796 pages of FDA Approval documents (975,781regular FDA & 308,015 FDA Classic Collection)
    • 53,750 FDA Approval documents (42,844 regular FDA & 10,906 FDA Classic Collection)
    • 4,016 Drugs with data in PharmaPendium
    • 872,048 extracted data lines in the Safety database
    • 2,231,684 AERS (post-marketing) reports

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