Apnimed announces FDA acceptance of new drug application for AD109, an investigational oral pill to treat adults with obstructive sleep apnoea

Apnimed

14 July 2026 - Apnimed today announced that the US FDA has accepted for review the new drug application filing of AD109 (aroxybutynin 2.3 mg/atomoxetine 75 mg) for the treatment of adults with obstructive sleep apnoea. 

The FDA has assigned a PDUFA target action date of 28 February 2027.

Read Apnimed press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration