TWi's ANDA for Metoprolol Succinate ER Tablets has been approved by US FDA

December 20, 2018. TWi Pharmaceuticals, Inc. (“TWi”) (Stock Ticker: 4180.TT) today announced that its ANDA (“Abbreviated New Drug Application”) of Metoprolol Succinate ER Tablets (TWi-011 and equivalent to Toprol XL®) has been officially approved by US FDA. The Company will start the preparation for launch in the US market accordingly.

Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension. According to IMS data, the total sales of Metoprolol Succinate ER Tablets in the US were approximately US $643 million for the 12 months ended October 2018.

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