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The FDA approvals of 2009

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by Maureen Martino and Liz Jones

 

Welcome to our look back at the new drug approvals of 2009. Last year the FDA gave the green light to an impressive 26 new therapies, slightly beating the 2008 total of 25. Of those, seven were newly-approved biologics, leading analysts to wonder whether 2009 was the year the biotech industry finally came into its own. The biggest NME winner was Novartis, which boasted four new approvals. The company was followed by Johnson & Johnson's Centocor Ortho Biotech and GlaxoSmithKline, with two approvals apiece.

 

Below is the list new drugs in order of date approved. Like other news outlets, FierceBiotech relied on the list of CDER approvals (not CBER approvals) provided by the FDA to compile this feature. Click here to begin the slideshow

 

1. Savella - Forest Labs

2. Uloric - Takeda

3. Afinitor - Novartis

4. Coartem - Novartis

5. Ulesfia - Sciele Pharma

6. Simponi - Johnson & Johnson

7. Dysport - Ipsen, Medicis

8. Fanapt - Vanda Pharma

9. Samsca - Otsuka Pharma

10. Besivance - Bausch & Lomb

11. Ilaris - Novartis

12. Multaq - Sanofi-Aventis

13. Effient - Eli Lilly, Daiichi Sankyo

14. Onglyza - AstraZeneca, BMS

15. Livalo - Kowa Research

16. Saphris - Merck's Organon USA

17. Extavia - Novartis

18. Sabril - Lundbeck

19. Bepreve - Ista Pharma

20. Vibativ - Theravance, Astellas

21. Folotyn - Allos Therapeutics

22. Stelara - Johnson & Johnson

23. Votrient - GSK

24. Arzerra - GSK

25. Istodax - Gloucester Pharma

26. Kalbitor - Dyax Corp.


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