As has been pointed out on many occasions, 2007 was a lean year for new drug approvals. The FDA approved only 17 new molecular entities (NMEs) last year--19 if you include two new biologics (Soliris and Mircera) OK'd by CDER. NMEs are perhaps the most important form of approval because they have never been approved by the FDA in any other form. The dearth of NMEs has industry watchers thinking that pharma's pipeline may be drying up, or that the FDA is getting stricter with its approval process--or both.
Many candidates missed the final goal last year, but here's a look at the drugs that made it through the rigorous drug discovery process and earned FDA approval in 2007.
1. Vyvanse [1] - New River Pharmaceuticals
2. Tekturna [2] - Novartis
3. Tykerb [3] - GlaxoSmithKline
4. Soliris [4] - Alexion
5. Altabax [5] - GlaxoSmithKline
6. Neupro [6] - Schwarz BioSciences
7. Torisel [7] - Wyeth
8. Letairis [8] - Gilead Sciences
9. Selzentry [9] - Pfizer
10. Ammonia N 13 [10] - Feinstein
11. Somatuline Depot [11] - Biomeasure
12. Doribax [12] - Johnson & Johnson
13. Isentress [13] - Merck
14. Ixempra [14] - Bristol-Myers Squibb
15. Tasigna [15] - Novartis
16. Mircera [16] - Roche
17. Kuvan [17] - BioMarin
18. Bystolic [18] - Forest Laboratories and Mylan
19. Voluven [19] - Fresenius Kabi
Click here [20] for special reports on biotech layoffs, R&D pipelines, industry trends, predictions and more.
Links:
[1] http://www.fiercebiotech.com/special-reports/vyvanse-2007-fda-approvals
[2] http://www.fiercebiotech.com/special-reports/tekturna-2007-fda-approvals
[3] http://www.fiercebiotech.com/special-reports/tykerb-2007-fda-approvals
[4] http://www.fiercebiotech.com/special-reports/soliris-2007-fda-approvals
[5] http://www.fiercebiotech.com/special-reports/altabax-2007-fda-approvals
[6] http://www.fiercebiotech.com/special-reports/neupro-2007-fda-approvals
[7] http://www.fiercebiotech.com/special-reports/torisel-2007-fda-approvals
[8] http://www.fiercebiotech.com/special-reports/letairis-2007-fda-approvals
[9] http://www.fiercebiotech.com/special-reports/selzentry-2007-fda-approvals
[10] http://www.fiercebiotech.com/special-reports/ammonia-n-13-2007-fda-approvals
[11] http://www.fiercebiotech.com/special-reports/somatuline-depot-2007-fda-approvals
[12] http://www.fiercebiotech.com/special-reports/doribax-2007-fda-approvals
[13] http://www.fiercebiotech.com/special-reports/isentress-2007-fda-approvals
[14] http://www.fiercebiotech.com/special-reports/ixempra-2007-fda-approvals
[15] http://www.fiercebiotech.com/special-reports/tasigna-2007-fda-approvals
[16] http://www.fiercebiotech.com/special-reports/mircera-2007-fda-approvals
[17] http://www.fiercebiotech.com/special-reports/kuvan-2007-fda-approvals
[18] http://www.fiercebiotech.com/special-reports/bystolic-2007-fda-approvals
[19] http://www.fiercebiotech.com/special-reports/voluven-2007-fda-approvals
[20] http://www.fiercebiotech.com/pages/top-5-archive