TWi's ANDA for Diltiazem HCl ER Capsules has been approved by US FDA

September 3, 2018. TWi Pharmaceuticals, Inc. (“TWi”) (Stock Ticker: 4180.TT) today announced that its ANDA (“Abbreviated New Drug Application”) of Diltiazem HCl ER Capsules (equivalent to Cardizem CD®) has been officially approved by US FDA. The Company will start the preparation for launch in the US market accordingly.

Diltiazem HCl ER Capsules are indicated for the treatment of hypertension and management of chronic stable angina and angina due to coronary artery spasm. According to IMS data, the total sales of Diltiazem HCl ER Capsules in the US were approximately US $218 million for the 12 months ended December 2017.

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