Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Teikoku Pharma USA for its new drug application (NDA) for Aricept Patch (donepezil hydrochloride), a transdermal patch formulation.
Subscribe to our email newsletter
Developed by Teikoku Pharma USA, a subsidiary of Teikoku Seiyaku, the Aricept Patch is a weekly transdermal patch intended to provide an alternative formulation for Alzheimer’s patients.
Teikoku Pharma USA and Eisai were seeking approval of the weekly Aricept Patch for the treatment of mild, moderate and severe stages of Alzheimer’s disease.
Eisai said it will work with Teikoku Pharma USA to assess the CRL and determine next steps.
Eisai, which holds the US marketing rights, will co-promote the Aricept Patch with Pfizer if approved.