Newsletter: Weekly FDA Review (10/15/2009) - Subscribe/Unsubscribe
- Final Approvals (2)
- Rejections (1)
- Orphan Drug Designations (1)
- Recommended Approvals (2)
- Fast Track Status (0)
- Complete Response Letters (0)
- Tentative Approvals (0)
- Priority Reviews (0)
- New Drug Applications (1)
- Alerts, Recalls and Shortages (1)
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1. Final Approvals
- CSL Behring Announces FDA Approval of Berinert
PR Newswire - APP Pharmaceuticals Receives Approval For Sumatriptan Succinate Injection
Medical News Today
2. Rejections
- Spectrum says FDA refuses to OK new plea on cancer drug
Reuters
3. Orphan Drug Designations
- Orphan Drug designation for NGR-hTNF in liver cancer
PharmaLive
4. Recommended Approvals
- US FDA panel backs wider use of Pfizer HIV drug
Reuters - Acorda’s Shares Surge After U.S. Panel Backs MS Drug
Bloomberg
9. New Drug Applications
- Perrigo files for generic version of Rogaine
Associated Press
10. Alerts, Recalls and Shortages
- ALERT: Relenza
FDA Notice
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