TAIPEI, June 3, 2015 -- TWi Pharmaceuticals, Inc. ("TWi") (stock ticker: 4180.TT) 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 Guanfacine HCl ER tablet, the generic equivalent to Shire Pharmaceutical's Intuniv®. TWI's marketing partner, Par Pharmaceuticals, will launch the product in the U.S. market immediately.
Intuniv® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). According to IMS Health, a market research firm, the total annual sales of Guanfacine HCl ER tablet in U.S. were approximately $751 million for the twelve months ending December, 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.
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