U.S. FDA approved Investigational New Drug(IND) application for clinical trial on Daewoong Pharmaceutical’s NABOTA

U.S. FDA approved Investigational New Drug(IND) application for clinical trial on Daewoong Pharmaceutical’s NABOTA -  The key process for FDA’s final approval is slated for completion by the end of 2015 Daewoong Pharmaceutical Co.,Ltd(President: Lee Jong-wook) announced on September 11 that the U.S. Food and Drug Administration(FDA) accepted the Investigational New Drug(IND) application of the U.S. importer Evolus to conduct clinical trial on NABOTA(.U.S. trade name: EVOSYAL). John Gross, MD, Chief Scientific Officer for Evolus, said, “NABOTA is the botulinum toxin consisting of high-purity 900kDa neurotoxin produced by the cutting-edge refining process of Daewoong Pharmaceutical which will aid in accomplishing predictable and long-lasting outcomes for both doctors and patients, and is expected to gain firm ground in the U.S. market.” Lee Bong-yong, Managing Director in charge of research division of Daewoong Pharmaceutical, said, “The Investigational New Drug(IND) application and its acceptance represent a critical milestone towards U.S. FDA’s final approval and are testament to the IND capability of Daewoong Pharmaceutical and Evolus which received the approval without question. This approval is an important step in bringing the best medicines to the U.S. consumers.” Lee Jong-wook, President of Daewoong Pharmaceutical, remarked, “NABOTA received the U.S. FDA’s final approval of preclinical studies submitted with the Investigational New Drug(IND) application without question, proving its effectiveness and safety. This clinical trial is expected to be completed by the end of 2015, and the U.S. FDA’s final approval of Investigational New Drug(IND) application for the clinical trial on NABOTA will ease the entry into the U.S. market.” The global market for toxin is worth approximately $2.7 billion(based on the period from the fourth quarter of 2012 to the third quarter of 2013), out of which the U.S. market is valued at $1.2 billion. The use of botulinum toxin for cosmetic applications already exceeded the milestone of 6 million cases.

The release as fetched from its publisher. daewoong.co.kr ↗