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
• EMA (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 EMA Approval Documents
  • 7,912 Increase of pages amount for EMA 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 EMA 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