J&J-McNeil To Co-Promote Cephalon ADHD Treatment Modafinil
This article was originally published in Pharmaceutical Approvals Monthly
Johnson & Johnson's McNeil Consumer & Specialty Pharma unit will add Cephalon's attention deficit/hyperactivity disorder treatment modafinil to its pediatric portfolio under a Sept. 1 co-promotion pact
You may also be interested in...
Cephalon is anticipating an early 2006 approval of Sparlon (modafinil, formerly Attenace) for attention deficit/hyperactivity disorder, the firm says Oct. 21. FDA deemed the agent "approvable" Oct. 20 for use in children and adolescents ages six to 17 years. The Sparlon NDA is based on three seven- to nine-week pivotal trials showing "significant improvement compared to placebo as early as the first week, with continued improvement during titration and dose maintenance," Cephalon says. The company announced an agreement in August to co-promote Sparlon with Johnson & Johnson's McNeil Consumer & Specialty Pharmaceuticals Division (1Pharmaceutical Approvals Monthly September 2005, p. 24)...
Cephalon goal of four NDA submissions in 14 months is on-track, with approvals forecast to double size of company by 2008. Pediatric sales force of 250 to be hired to detail modafinil for ADHD, with debut slated for early 2006. FDA rejects trade name Attenace. OraVescent breakthrough cancer pain NDA slated for Q3 2005; Gabitril sNDA for generalized anxiety in Q1 2006
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011