Sepracor revises timing of commercial availability for Lunesta brand eszopiclone
MARLBOROUGH, MASS., January 11, 2005 -- Sepracor announced a revision to the anticipated commercial availability of Lunesta brand eszopiclone for the treatment of insomnia.
On December 15, 2004, the FDA approved the New Drug Application
(NDA) for Lunesta for the treatment of insomnia. As
expected, the FDA recommended that Lunesta, like all other non-benzodiazepine hypnotics, be classified as a Schedule IV controlled substance by the Drug Enforcement Administration (DEA).
The Federal government's administrative process for formally classifying Lunesta as a Schedule IV controlled substance is not yet complete. Because of uncertainties regarding marketing the product prior to completion of scheduling, Sepracor's plan to make Lunesta commercially available in early January 2005 is no longer feasible. Sepracor is currently working with the FDA and DEA to resolve these uncertainties and conclude final administrative actions related to the scheduling of Lunesta.
At this time, Sepracor anticipates that Lunesta will be available to patients nationwide within the first quarter of 2005.
Source: Sepracor Inc. www.sepracor.com
Posted: January 2005