TWi Pharmaceuticals Announces Tentative ANDA Approval for Guanfacine Hydrochloride Extended-Release Tablets
TAIPEI, Taiwan, May 14, 2013 /PRNewswire/ -- TWi Pharmaceuticals, Inc. (Taiwan OTC: 4180) today announced that it has received tentative approval for its Abbreviated New Drug Application (ANDA) for Guanfacine Hydrochloride Extended Release Tablets 1mg, 2mg, 3mg and 4mg from the United States Food and Drug Administration (U.S. FDA). Guanfacine Hydrochloride Extended-Release Tablet is a central alpha2A-adrenergic receptor agonist indicated for the treatment of Attention Deﬁcit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.
"We are pleased to receive the tentative approval from U.S. FDA for our Guanfacine Hydrochloride product," said Dr. Calvin C. Chen, President of TWi Pharmaceuticals. "TWi had already reached a settlement agreement with the branded product manufacturer and intends to begin shipping its Guanfacine Hydrochloride product upon receiving the final approval from U.S. FDA."
According to IMS Health, a market research firm, the total annual sales of the branded product, Intuniv®, marketed by Shire US Inc., in U.S. were approximately $448 million in 2012.
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.
Michael L. Huang
Head of Investor Relations
SOURCE TWi Pharmaceuticals, Inc.