Please login to the form below

Not currently logged in
Email:
Password:

FDA declines approval for Eisai's Aricept

Eisai has received a complete response letter from the US Food and Drug Administration declining approval for the transdermal patch formulation of Eisai's Alzheimer's treatment Aricept

Eisai has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) declining approval for the transdermal patch formulation of Eisai's Alzheimer's treatment Aricept (donepezil hydrochloride).

The FDA has requested more information regarding the formulation and usage of the form of treatment.

Eisai has said it will collaborate with its US partner, Teikoku Pharma, and work with FDA to assess the complete response letter and determine next steps.

Teikoku developed the transdermal patch formulation of Aricept based on licence agreements with Eisai.

In June 2010, Teikoku submitted a new drug application to the FDA seeking approval to use the specific formulation of Aricept in the treatment of mild, moderate and severe stages of Alzheimer's disease.

26th April 2011

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Create Health

A healthcare marketing agency that shares your passion for making things better. Our clients with solve real health problems every...

Latest intelligence

Article
How will COVID-19 affect uptake of vaccinations against other diseases?...
Top 10 Reasons Why Virtual Collaboration and Medical Education Will Persist in the New Normal
Even after the pandemic is long behind us, virtual collaboration will become mainstay in Pharma....
Podcast
Living With Chronic Illness (Series one)...

Infographics