Eisai receives FDA Complete Response Letter for Aricept Patch NDA

Eisai announced today that the United States Food and Drug Administration (FDA) issued a Complete Response Letter to Teikoku Pharma USA, Inc., regarding the New Drug Application (NDA) of the Aricept® Patch (donepezil transdermal system). The Aricept Patch was developed by Teikoku Pharma USA, Inc, a subsidiary of Teikoku Seiyaku Co., Ltd. Teikoku Pharma USA, Inc. and Eisai were seeking approval of the weekly Aricept Patch for the treatment of mild, moderate and severe stages of Alzheimer's disease.

The FDA issues a Complete Response Letter to indicate that the review cycle of an application is complete and the application is not ready for approval. Eisai will work with Teikoku Pharma USA to assess the Complete Response Letter and determine next steps. Eisai holds the marketing rights in the United States and will co-promote the Aricept Patch with Pfizer if approved.

The Aricept Patch is a weekly transdermal patch that was developed to provide an alternative formulation for Alzheimer's patients. Eisai has a long-standing commitment to the treatment of Alzheimer's disease and is dedicated to supporting the Alzheimer's disease community.



The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Innovative startups leading the charge in alternative proteins to solve global food crisis