Transcept Gains Long-Delayed Approval Of Intermezzo
This article was originally published in The Pink Sheet Daily
Indication for insomnia characterized by middle-of-the-night awakening followed by difficulty returning to sleep is a first.
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FDA signals comfort with declaring low dose of at least one insomnia product as OK for next-day driving, but suvorexant’s fate will depend on Merck’s data.
CDER officials explain the rationale behind new labeling on zolpidem-containing immediate- and controlled-release products that halves the recommended dose for women. Labeling changes include a new precaution against next-day driving following use of Sanofi’s Ambien CR.
Agency will require driving simulation studies for all new sleep aids and is asking sponsors of currently approved products to conduct such trials. FDA is directing zolpidem-containing product manufacturers to make labeling changes based, in part, on driving data submitted for Transcept’s Intermezzo.