2007 FDA approvals

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 - New River Pharmaceuticals

2. Tekturna - Novartis

3. Tykerb - GlaxoSmithKline

4. Soliris - Alexion

5. Altabax - GlaxoSmithKline

6. Neupro - Schwarz BioSciences

7. Torisel - Wyeth

8. Letairis - Gilead Sciences

9. Selzentry - Pfizer

10. Ammonia N 13 - Feinstein

11. Somatuline Depot - Biomeasure

12. Doribax - Johnson & Johnson

13. Isentress - Merck

14. Ixempra - Bristol-Myers Squibb

15. Tasigna - Novartis

16. Mircera - Roche

17. Kuvan - BioMarin

18. Bystolic - Forest Laboratories and Mylan

19. Voluven - Fresenius Kabi


Click here for special reports on biotech layoffs, R&D pipelines, industry trends, predictions and more.


Suggested Articles

The data, from two patients with severe blood disorders, are "promising” for what could be a one-and-done treatment, Cantor Fitzgerald analysts wrote.

The fund will back pharma companies as well as developers of medtech products and providers of outsourced services.

The money will fund work to develop polymers in multiple indications and an associated U.S. expansion.