01.02.2012 FDA Approved No Comments

2011 FDA Approvals

By Liz Jones Hollis and Jennifer Levin
Welcome to our annual look back at FDA approvals. 2011 was a big year for drugmakers seeking to get their innovative products approved, as the FDA was busy. In fact, the agency approved 30 new drugs last year (a 7-year high). Among the lucky bunch who got an FDA nod were Johnson & Johnson ($JNJ) and GlaxoSmithKline ($GSK), both of which snagged three approvals each.

The FDA itself has been quick to point to its record of success in 2011, highlighting its sign-off on such novel treatments as Seattle Genetics’ ($SGEN) new lymphoma drug Adcetris.
But will the numbers hold up this year? Drugmakers are facing increasing competition from their generic foes, and, after a period of unproductive R&D, the number of approvals could drop in coming years. Still, as we have discussed in our “15 top blockbuster contenders” report, the biopharma industry still has what it takes to develop innovative products.
1. Adcetris – Seattle Genetics
2. Anascorp – Rare Disease Therapeutics
3. Arcapta Neohaler – Novartis
4. Ardovax – Teva Women’s Health
5. Benlysta – Human Genome Sciences, GSK
6. Brilinta – AstraZeneca
7. Caprelsa – AstraZeneca
8. Corifact – CSL Behring
9. Daliresp – Forest Labs, Nycomed
10. DaTscan – GE Healthcare
11. Dificid – Optimer Pharmaceuticals
12. Edarbi – Takeda Pharmaceutical
13. Edurant – Tibotec Therapeutics
14. Firazyr – Shire
15. Gadavist – Bayer Pharmaceuticals
16. Horizant – GSK, Xenoport
17. Incivek – Vertex Pharmaceuticals
18. LaViv – Fibrocell Science
19. Natroba – ParaPRO Pharmaceuticals
20. Nulojix – Bristol-Myers Squibb
21. Potiga – GSK, Valeant
22. Spherusol – Allermed Laboratories
23. Tradjenta – Boehringer Ingelheim, Eli Lilly
24. Victrelis – Merck
25. Viibryd – Cinical Data, Trovis, Forest
26. Xalkori – Pfizer
27. Xarelto – Bayer Pharmaceuticals
28. Yervoy – Bristol-Myers Squibb
29. Zelboraf – Genentech, Daiichi Sankyo
30. Zytiga – Roche

Read more: FDA approvals of 2011 – FierceBiotech http://www.fiercebiotech.com/slideshows/fda-approvals-2011#ixzz1l9lWTJYN

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