The FDA approvals of 2009
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 ⇒
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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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