SparlonTreatment for ADHD in Children and Adolescents
Cephalon, Inc. Provides Update on Regulatory Status of Sparlon
FRAZER, Pa., January 25, 2006 -- Cephalon, Inc. announced today that it does not expect final action from the FDA on its pending new drug application for Sparlon (modafinil) Tablets [C-IV] for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents until after the completion of several FDA advisory committee meetings. The first two panels, scheduled for February 9, 2006 and March 22, 2006, will consider safety and risk management issues associated with products in the class of currently approved ADHD treatments. Since Sparlon is not an approved drug, it will not be discussed at these meetings. A separate advisory panel to review Sparlon has been scheduled for March 23, 2006. On October 20, 2005, the FDA issued an approvable letter with respect to the company's NDA for Sparlon. The company now expects to launch Sparlon during the second quarter of 2006.
As a result of recent settlements of three patent infringement suits related to Provigil (modafinil) Tablets [C-IV], the closing of the Zeneus acquisition, the current timeline for commercial launch of Sparlon, and the impact of the recent rise in the company's stock price on the number of shares included in the income per share calculation, the Company has determined its previously issued 2006 sales and diluted adjusted income per share guidance is outdated. The Company will reissue 2006 guidance when it releases its fourth quarter and full year 2005 financial results on February 14, 2006.
Source: Cephalon, Inc.
Posted: January 2006
- Cephalon Receives Non-Approvable Letter on Sparlon - August 9, 2006
- FDA Advisory Committee Recommends Against Approval of Sparlon for Attention Deficit/Hyperactivity Disorder in Children and Adolescents - March 23, 2006
- Cephalon Receives Approvable Letter for Sparlon for the Treatment of ADHD in Children and Adolescents - October 21, 2005
- Cephalon Files Application for Marketing Approval of New Modafinil Formulation for the Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder - December 21, 2004