2014.10
TWi Pharmaceuticals Receives US FDA Approval on Generic Donepezil Hydrochloride Tablets USP, 23 mg, its fifth ANDA from US FDA

October 30, 2014. TWi Pharmaceuticals, Inc. today announced that it has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride Tablets USP, 23 mg, the generic equivalent to Eisai Inc.'s Aricept® 23mg. Aricept® 23mg is used to treat Alzheimer's disease patients.

 

TWi Pharmaceuticals is preparing to launch the product in the US via its fully owned subsidiary, TWi Pharmaceuticals USA, at the earliest time possible.

 

According to IMS Health, US sales of Aricept® 23mg were approximately $78 million for the 12 months ended June 2014.

 

About TWi Pharmaceuticals, Inc.

TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier generic prescription products ranging from oral controlled release dosage form to novel drug delivery systems including the utilization of nanoparticles, transdermal, and polymeric oral delivery systems. Leveraging its internal research and development capabilities, together with operational flexibility, process development, manufacturing and regulatory expertise, TWi Pharmaceuticals concentrates on products and technologies that present significant barriers to entry or offer Paragraph IV first-to-file or first-to-market opportunities in the United States. For more information of TWi Pharmaceuticals, please visit www.twipharma.com.

 

Contact:

Eric Lin

Investor Relations

Tel: +886-2-2657-3350 ext. 407

email: eric.lin@twipharma.com

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