Modafinil: Notice of Intent to Revise

In accordance with the 2005-2010 Rules and Procedures of the Council of Experts, the Monograph Development–Pulmonary and Steroids Expert Committee intends to revise the Modafinil monograph based on comments received. Several specifications will be updated pending final FDA approval for tentatively approved Abbreviated New Drug Application (ANDA) holders.

It is anticipated that the proposed revisions will be published as a Revision Bulletin.

Should you have questions, please contact Mary Waddell (301-816-8124 or ).