- FDA approves Plan B One-Step OTC switch
- Senate passes Drug Quality and Security Act
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- FDA approves liquid form of enalapril to treat BP in children, adults
- Former CMS, FDA chief McClellan delivers keynote at Cardinal Health RBC
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has asked Eisai to redo its regulatory application for a drug to treat epilepsy, Eisai said Friday.
The drug maker said the FDA issued a refusal to file letter in response to its application for perampanel, designed to treat partial-onset seizures in patients with epilepsy. In the letter, the FDA requested reformatting and reanalyses of some datasets, though Eisai said new studies probably were unnecessary.
Eisai said it would work with the FDA to provide the information requested so that it can resubmit the application.