Merck’s Suvorexant Driving Claims May Get Green Light After Lunesta Re-Label
This article was originally published in The Pink Sheet Daily
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.
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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.
Indication for insomnia characterized by middle-of-the-night awakening followed by difficulty returning to sleep is a first.
FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments
Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs.