Wednesday, January 16, 2008

2007 FDA approvals

I haven't seen these numbers in a couple of years...

As has been pointed out on many occasions, 2007 was a lean year for new drug approvals. The FDA approved only 15 new molecular entities (NMEs) last year--17 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.

link to full article from FiercePharma

No comments: