Teikoku Pharma USA Announces FDA Accepts Aricept(R) Patch (Donepezil Transdermal System) NDA For Review

Main Category: Alzheimer's / Dementia
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 21 Sep 2010 - 0:00 PDT


Teikoku Pharma USA, Inc., an international specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a new weekly transdermal patch of Aricept(R), a leading medication for the treatment of Alzheimer's disease.

The company developed the weekly Aricept® patch based on a license agreement executed between Teikoku Pharma USA, Inc. and Eisai Co., Ltd. (Eisai) in February 2009. The acceptance of the NDA indicates that the FDA deems the company's submission to be sufficient to review. The NDA was submitted to the FDA by Teikoku Pharma USA, Inc. on June 30, 2010. If approved, Eisai's subsidiary, Eisai Inc., will hold marketing rights in the U.S.

The Aricept® transdermal patch formulation employs a unique drug delivery system, making it the world's first weekly transdermal patch for the treatment of Alzheimer's disease. It was developed to provide a potential new treatment option to Alzheimer's disease patients who have trouble swallowing, as well as to reduce the burden on caregivers and family members who administer medication to patients.

About Teikoku

Teikoku Pharma USA, Inc., a wholly-owned subsidiary of Teikoku Seiyaku Co., Ltd. that is a leading supplier of the topical analgesic transdermal patch, Lidoderm®, in the world, is a specialty pharmaceutical company that develops and manufactures enhanced pharmaceutical products with its transdermal drug delivery technology. Teikoku focuses its efforts on two therapeutic areas: chronic and acute pain, and the central nervous system (CNS). The company looks forward to exploring a new field of CNS with the systemic transdermal patch. Teikoku is committed to applying its transdermal technology for the benefit of patients and partners.

Source:
Eisai Co., Ltd.

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