FDA On Pace To Approve 18 New Drugs In 2008

The U.S. Food and Drug Administration has approved nine new medicines as of the end of June, putting it on pace to be one of the slowest years for new drug approvals in the last five years.

Drugs approved this year include Wyeth's (WYE) Pristiq, used to treat depression, Cephalon Inc.'s (CEPH) leukemia drug Treanda and UCB SA's (UCB.BT) Cimzia for Crohn's disease, which causes irritation in the digestive tract.

The agency approved 18 "new molecular entities," which means the active ingredient hadn't been used before in an FDA-approved therapy, in 2007. The agency could approve a similar amount if its pace continues. The agency approved 22 such drugs in 2006.

Pharmaceutical companies have decried what it sees as the FDA's increasingly tough stance on safety, saying it is making it too hard to get drugs approved. The FDA has said it hasn't become more conservative about safety but blames the companies' faltering research for any decrease in drug approvals.

FDA spokeswoman Sandy Walsh said the agency may approve more, or fewer, drugs in the second half of the year. Such a number is hard to nail down, because the agency reviews drugs as they come in and some may require more time than others.

Walsh said the agency doesn't track the number of pending drug applications.

To be sure, the number of drugs approved has varied over the years. The agency approved 17 truly new drugs in 2002, and 22 in 2006.

SOURCE: Food And Drug Administration