FDA review may force extension of Nuvigil deadline

The FDA is continuing to investigate a case of sometimes fatal rash that developed during a clinical trial of Sparlon, an experimental therapy for sleep disorder, according to an announcement from Cephalon. And that investigation could cause a delay in the agency's decision on Nuvigil, a next-generation therapy that follows Provigil. All three therapies rely on modafinil as the active ingredient. Cephalon says that the time needed to finish the Sparlon review may require an extension of the FDA's Dec. 31 deadline for a decision on its Nuvigil application. The FDA issued an approvable letter for Nuvigil earlier this year.

- here's the report [1] on Cephalon from the Philadelphia Business Inquirer

Related Articles:
Cephalon provides update on Sparlon. Report [2]
FDA committee rejects Cephalon's Sparlon. Report [3]
FDA issues approvable letter for Nuvigil. Report [4]