TWi's ANDA for Fenofibric Acid DR Capsules has been approved by US FDA

July 9, 2019 . TWi Pharmaceuticals, Inc. (“TWi”) (Stock Ticker: 4180.TT) today announced that its ANDA (“Abbreviated New Drug Application”) of Fenofibric Acid DR Capsules (equivalent to Trilipix®) has been officially approved by US FDA. The Company will start the preparation for launch in the US market accordingly.

Fenofibric Acid DR Capsules are indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia.. According to IMS data, the total sales of Fenofibric Acid DR Capsules in the US were approximately US $41 million for the 12 months ended May 2019.

About TWi Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier to entry generic prescription products ranging from oral controlled release dosage forms 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 unparalleled market opportunities in the United States. For more information on TWi Pharmaceuticals and its fully owned US subsidiary, TWi Pharmaceuticals USA, Inc., please visit www.twipharma.com

Contact :
Angela Luan
Finance/ Investor Relations
Email: angela.luan@twipharma.com