2020-10
TWi’ ANDA for Dimethyl Fumarate DR Capsules (equivalent to Tecfidera®) has been officially approved by US FDA
October 21, 2020 . TWi Pharmaceuticals, Inc. (“TWi”) today announced that its ANDA (“Abbreviated New Drug Application”) for Dimethyl Fumarate DR Capsules (equivalent to Tecfidera®) has been officially approved by US FDA. The Company will start the preparation for launch in the US market accordingly.
 
Dimethyl Fumarate DR Capsules are indicated treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. According to IQVIA data, the total sales of Dimethyl Fumarate DR Capsules in the US were approximately US $3.7 billion for the 12 months ended August 2020.
 
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

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