Sepracor Lunesta Cancer Risk At Center Of FDA Approvability Debate
This article was originally published in The Pink Sheet Daily
Reviewing division's "not approvable" recommendation is overruled by Office Director Temple, FDA review documents show.
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For the week ending April 15, the insomnia agent brought in 21,381 new scripts, resulting in a 5.1% market share, Sepracor said. "It looks like…the principal new Rxs are coming from [Sanofi-Aventis'] Ambien," the company said. Sepracor is planning to pursue labeling adaptations to increase Lunesta's market potential.
The company expects FDA will take six months to review the eszopiclone resubmission. Sepracor had earlier expressed optimism about a two-month review, which would have set an approval target for the sleep agent around mid-year.
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