Newsletter: Weekly FDA Review (10/15/2009) - Subscribe/Unsubscribe


PharmacyOneSource.comWeekly FDA Review - 15.October.2009
  1. Final Approvals (2)
  2. Rejections (1)
  3. Orphan Drug Designations (1)
  4. Recommended Approvals (2)
  5. Fast Track Status (0)
  6. Complete Response Letters (0)
  7. Tentative Approvals (0)
  8. Priority Reviews (0)
  9. New Drug Applications (1)
  10. Alerts, Recalls and Shortages (1)

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1. Final Approvals
  1. CSL Behring Announces FDA Approval of Berinert
    PR Newswire
  2. APP Pharmaceuticals Receives Approval For Sumatriptan Succinate Injection
    Medical News Today

2. Rejections
  1. Spectrum says FDA refuses to OK new plea on cancer drug
    Reuters

3. Orphan Drug Designations
  1. Orphan Drug designation for NGR-hTNF in liver cancer
    PharmaLive

4. Recommended Approvals
  1. US FDA panel backs wider use of Pfizer HIV drug
    Reuters
  2. Acorda’s Shares Surge After U.S. Panel Backs MS Drug
    Bloomberg

9. New Drug Applications
  1. Perrigo files for generic version of Rogaine
    Associated Press

10. Alerts, Recalls and Shortages
  1. ALERT: Relenza
    FDA Notice


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