The green light has been given by the FDA to ‘Tedizolid’, a super antibiotic, developed by Dong-A to fight super bacteria.
On 1 April 2014, Dong-A ST (President Park Chan-il) announced that ‘Tedizolid (product name: SIVEXTROTM)’ targeting super bacteria was given a unanimous support by FDA’s Anti-Infective Drugs Advisory Committee for the FDA approval of the new drug. Dong-A exported the technology for ‘Tedizolid’ to Trius Therapeutics (currently Cubist) of the USA in January 2007.
At a meeting of the advisory committee held on the morning of March 31, Eastern Standard Time of the USA, all 14 members unanimously supported the FDA approval of ‘SIVEXTRO.’ The FDA is bound to finish its priority review by June 20, 2014.
“The opinion of the FDA Anti-Infective Drugs Advisory Committee impacts the FDA approval decision greatly, and so we are hopeful for the FDA final review and approval of Tedizolid in June.” said President Park Chan-il. “The prospect of Tedizolid developed by Dong-A ST to fight super bacteria emerging as new global medicine is becoming clearer.”
In the meantime, ‘SIVEXTRO’ passed the EMA’s preliminary assessment of Dong-A ST’s marketing authorization application at the beginning of 2014. The final approval is expected in the first half of 2015.