Eisai resubmits Perampanel NDA to FDA

Tuesday, December 27, 2011 01:28 PM

Eisai has resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the FDA. This resubmission comes after the FDA issued a Refusal to File letter in July 2011 in which FDA requested reformatting and reanalyses of some datasets in the dossier. The application was originally submitted in May 2011.

The FDA will determine acceptance of filing within 60 days of submission.

Share:          
CWWeekly

May 21

Parexel consultant testifies on FDA biosimilars guidance

Global Telecom Testing checks ex-U.S. toll-free phone lines for multinational clinical trials

To read the full articles for this issue of CWWeekly, please click here for subscription information.

Already a digital subscriber? Access this issue now.

CWWeekly

May

Newer sites most optimistic about the future
Investigative sites of all sizes, from part-time physician-run sites to large dedicated research centers, report a rebound in operating conditions, according to a new CenterWatch analysis, yet sites from each subgroup indicate they have concerns…

Risk-based monitoring slow to catch on with industry
It's estimated that the cost of physically sending monitors to all investigative sites at regular intervals, a model the industry itself developed and has adhered to for about a decade, eats up one-third to one-half of…

Eye On Millennium
Millennium, The Takeda Oncology Company, discovers and develops novel treatments applying world-class recombinant technology to a wide variety of oncology disease targets…

To read the full articles for this issue of The CenterWatch Monthly, please click here for subscription information.

Already a digital subscriber? Access this issue now.

JobWatch centerwatch.com/jobwatch

Featured Jobs