Sparlon
Generic name: modafinil
Treatment for: ADHD in Children and Adolescents
Cephalon Receives Approvable Letter for Sparlon for the Treatment of ADHD in Children and Adolescents
Sparlon is a new formulation and proprietary dosage strength of modafinil, the active ingredient in Provigil (modafinil) Tablets [C-IV], which is approved for the treatment of adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. Provigil is not approved to treat ADHD and is available only in 100 mg and 200 mg strengths. If approved, Sparlon is expected to be available in early 2006.
Posted: October 2005
Related articles
- 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, Inc. Provides Update on Regulatory Status of Sparlon - January 25, 2006
- 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
Sparlon (modafinil) FDA Approval History
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