TWi's ANDA for Oxcarbazepine ER Tablets has been tentatively approved by US FDA

November 30, 2018. TWi Pharmaceuticals, Inc. (“TWi”) (Stock Ticker: 4180.TT) today announced that the Company received tentative approval for its ANDA (“Abbreviated New Drug Application”) for Oxcarbazepine ER Tablets (generic version of Oxtellar XR®) from US FDA. The Company expects to launch the product as soon as the patents are expired.

Oxcarbazepine ER Tablets are indicated as adjunctive therapy of partial seizures. According to IMS data, the total sales of Oxcarbazepine ER Tablet in the US were approximately US $130 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