New Delay for Nuvigil

Cephalon (CEPH Quote) has been hit with another regulatory delay for its sleep-disorder drug Nuvigil.

After the markets had closed on Friday, the company said the Food and Drug Administration issued another conditional approval letter for the drug, which, Cephalon says, will be sold for three types of sleep problems.

The agency has asked Cephalon to provide "a standard safety update from clinical trials conducted since the last update in June 2006," as well as promotional materials to be used for the product, the company said. Cephalon will respond within 30 days. It expects the agency to complete a review within 60 days after the response. The FDA hasn't asked for extra tests. ...