Sepracor Lunesta Launch Delayed By Controlled Substance Scheduling
This article was originally published in The Pink Sheet Daily
Executive Summary
Sepracor plans for Lunesta to be available within the first quarter of 2005 after the completion of formal Drug Enforcement Agency classification of eszopiclone as a Schedule IV substance. The company originally planned to launch the insomnia agent in early January following FDA approval in December.
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Sepracor Insomnia Spot Suggests Lunesta “Product And Use” Ads Coming Soon
The unbranded spot tells patients suffering from insomnia to stay tuned for more information coming April 24 about “something on its way that could change your nights.” The ad first aired April 10. Sepracor is also planning to discuss labeling revisions with FDA based on its second six-month trial.
Sepracor Insomnia Spot Suggests Lunesta “Product And Use” Ads Coming Soon
The unbranded spot tells patients suffering from insomnia to stay tuned for more information coming April 24 about “something on its way that could change your nights.” The ad first aired April 10. Sepracor is also planning to discuss labeling revisions with FDA based on its second six-month trial.
Lunesta Scripts Limited To Five Refills Under Proposed DEA Scheduling
DEA proposes scheduling Sepracor’s sleep aid as a Schedule IV controlled substance limited to five refills in a six-month period. Under the proposed rule, all dispensers and distributors of Lunesta would be required to be registered and to keep on hand inventories of eszopiclone.