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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

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