drugset / Press release

Daewoong Pharmaceutical’s botulinum toxin becomes the first Korea-made Botulinum Toxin to obtain US FDA approval

2019-02-19 · Daewoong Pharmaceutical Co. LTD. · original daewoong.co.kr ↗

Daewoong Pharmaceutical’s botulinum toxin becomes the first Korea-made botulinum toxin product to obtain US FDA approval -  Targeting the world’s largest U.S. market with the FDA approval -  Scheduled to be launched in the US market in the spring of 2019. ‘Jeuveau,’ which is Daewoong Pharmaceutical’s independently developed Botulinum Toxin, will be launched in the U.S. market. Daewoong Pharmaceutical (CEO Sengho Jeon) announced last 1st (US time) that Jeuveau has finally been approved by the U.S. FDA for the treatment of frown lines. Therefore, it has become the first Botulinum Toxin product of Korea to be sold in the world’s greatest U.S. market. In 2014, it was developed by the ‘High-pure Technology’ to reduce the alien matters for higher purity.  In Korea, Nabota has been approved by KFDA for frown lines, wrinkles around the eye area, and upper spasticity after a stroke. Nabota is produced and supplied by a state-of-the-arts facility with cGMP certification and has proven its safety and efficacy through a 3-phase clinical studies on more than 2,100 patients in the U.S., Europe, and Canada. Jeuveau will be sold by Evolus, the local partner specialized in selling products for aesthetics, in the U.S. Alphaeon, the parent company of Evolus, was established by more than 200 opinion leaders in the American Society for Aesthetic Plastic Surgery and has a powerful network of practitioners throughout the U.S.  Evolus is planning to release Jeuveau in the coming spring and enter the Toxic market with aggressive customer-centered marketing strategies.  According to Daedal Research and Bloomberg, the world’s Botulinum Toxin market is about 4 trillion KRW in scale and the U.S. market currently takes over half of it with an increase of more than 9% every year. “It is a great honor that Daewoong's product has been approved by the U.S. FDA and we are able to provide a competitive solution for the treatment of frown lines the practitioners and patients within the world’s greatest Botulinum Toxin market in the U.S.,” said CEO Sengho Jeon. “As it's exceptional quality, safety, and efficacy have been proven, we are positive about its success in North America. Jeuveau’s FDA approval is a big step for the local pharmaceuticals in Korea and a great turning point for Daewoong’s leap to become a global healthcare company.” “Evolus will be able to introduce a new product to the American aesthetic Neurotoxin market for the first time in about a decade,” said President David Moatazedi of Evolus.  “We will make efforts for Jeuveau’s successful release based on our professional knowhow and strategies in marketing.” As of today, Daewoong's botulinum toxin has signed sales contracts in about 80 countries around the world, including the U.S., Canada, Europe, Australia, Central/South America, and the Middle East.  With the FDA approval, it can be sold in 16 countries.  Also, the deliberation of EMA in Europe is also progressing smoothly with some updates on its approval expected during the first half of the year. #  #  #

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