TWi's ANDA for Testosterone Gel 1.62% Pump CIII has been approved by US FDA

September 26, 2019 . TWi Pharmaceuticals, Inc. (“TWi”) today announced that its ANDA (“Abbreviated New Drug Application”) for Testosterone Gel 1.62% Pump CIII (equivalent to Androgel®) has been officially approved by US FDA. The Company will start the preparation for launch in the US market accordingly.

Testosterone Gel 1.62% Pump CIII is indicated as testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism. According to IQVIA data, the total sales of Testosterone 1.62% Pump CIII in the US were approximately US $520 million for the 12 months ended July 2019.

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