Sepracor Inc.
Commercial availability date for eszopiclone treatment for insomnia revised
Published in Drug Law Weekly, February 8th, 2005
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 nonbenzodiazepine hypnotics, be classified as a Schedule IV controlled substance by the U.S. 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...
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Source: Drug Law Weekly (2005-02-08)
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