Enabling Swift and Safe Healthcare Worldwide

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

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1. Final Approvals

1. Qutenza Approved for Post-Shingles Nerve Pain
   HealthDay
   
2. Glenmark Generics gets FDA nod for Ciclopirox Olamine
   Business Standard
   
3. Par Pharma gets FDA approval for generic Ultram ER
   Associated Press
   
4. FDA Approves Lysteda To Treat Heavy Menstrual Bleeding
   Medical News Today

2. Rejections

1. Genzyme's Pompe drug rejected
   Reuters
   
2. CombinatoRx dives on FDA rejection
   Bloomberg News

4. Recommended Approvals

1. FDA panel OKs new kids' pneumococcal shot
   Associated Press

6. Complete Response Letters

1. Genentech, Biogen get FDA request on Rituxan
   Associated Press
   
2. HGS's anthrax drug delayed by FDA
   Washington Post

7. Tentative Approvals

1. Sun Pharma wins FDA tentative approval for generic leukemia drug
   Trading Markets

8. Priority Reviews

1. FDA to review Actelion's Zavesca for additional use
   Reuters

9. New Drug Applications

1. AstraZeneca asks for U.S. approval of Brilinta
   Reuters

10. Alerts, Recalls and Shortages

1. ALERT: Clopidogrel
   FDA Notice
   
2. ALERT: Genzyme
   FDA Notice
   
3. Alert: Local Anesthetics
   FDA Notice

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