The development of Sparlon for attention deficit disorder has ceased but the FDA might delay its labeling decision concerning Nuvigil as it is a single-isomer formulation of modafinil, the chemical name for Sparlon.
The FDA has requested additional information to help with its decision and determine the safety profile for modafinil, although the regulator has not requested any additional information related to Nuvigil.
The company is in the process of collecting the requested information and expects to make the submission to the FDA within the next few weeks. In May, the company received an approvable letter for the new drug application requesting approval of Nuvigil for the treatment of excessive sleepiness. FDA approval of Nuvigil is contingent upon finalizing the product label.