Enabling Swift and Safe Healthcare Worldwide

1. Final Approvals (11)
2. Rejections (2)
3. Orphan Drug Designations (0)
4. Recommended Approvals (0)
5. Fast Track Status (1)
6. Complete Response Letters (3)
7. Tentative Approvals (0)
8. Priority Reviews (0)
9. New Drug Applications (1)
10. Alerts, Recalls and Shortages (2)

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1. Final Approvals

1. FDA Approves Gardasil Vaccine for Boys, Cervarix for Girls
   The Wall Street Journal
   
2. FDA Approves Micardis (Telmisartan) As the First Treatment in its Class to Reduce the Risk of Heart Attack, Stroke, or Death from Cardiovascular Causes
   Business Wire
   
3. FDA approves Crestor for high cholesterol kids
   Associated Press
   
4. Talecris Biotherapeutics Receives FDA Approval for Prolastin-C
   PR Newswire
   
5. FDA clears Sanofi for adults with cancer
   Associated Press
   
6. Mylan gets FDA approval for generic Topamax
   Associated Press
   
7. FDA Approves Colcrys (colchicine, USP) for Prevention of Gout Flares
   PR Newswire
   
8. FDA Approves Twynsta (telmisartan plus amlodipine) a New Single Pill Combination That Delivers Blood Pressure Reductions for 24 Hours
   Business Wire
   
9. FDA Approves New Treatment for Advanced Form of Kidney Cancer
   PR Newswire
   
10. APP Pharma cleared by FDA for hypertension drug
    MarketWatch
    
11. FDA Expands Flu Vaccine Indication
    MedPage Today

2. Rejections

1. FDA nixes wider use of rheumatoid arthritis drug
   Associated Press
   
2. FDA declines to approve King's heart imaging drug
   Reuters

5. Fast Track Status

1. MacuSight Receives Fast Track Designation From FDA for Perceiva in Treatment of Diabetic Macular Edema
   PR Newswire

6. Complete Response Letters

1. FDA letter delays OK for Amgen bone drug Prolia
   Associated Press
   
2. U.S. Seeks More Information on Novartis Lung Drug
   Reuters
   
3. Endo Pharma Gets Complete Response Letter On Fortesta Testosterone Gel From FDA
   RTT News

9. New Drug Applications

1. Questcor Resubmits Supplemental New Drug Application to FDA for H.P. Acthar Gel
   Global Newswire

10. Alerts, Recalls and Shortages

1. RECALL: Ketorolac
   FDA Notice
   
2. ALERT: Dexferrum
   FDA Notice

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