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Commercial Availability for Lunesta Delayed
On December 15, 2004, the U.S. Food and Drug Administration (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 diligently 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.
"All commercial activities, including manufacturing, supply chain and sales and marketing required for a successful launch, are firmly in place," said W. James O'Shea, President and Chief Operating Officer at Sepracor.
Source: Sepracor Inc.