South Korea’s Daewoong Pharm Co. Monday announced the United States Adopted Name (USAN) for its botulinum toxin Nabota has been registered as Prabotulinumtoxin A.
The toxin, better known as botox, is used for anti-wrinkle treatments and facelifts.
The USAN is one of internationally-accepted names for an active ingredient and is officially backed by the American Medical Association (AMA) to ensure safety, consistency and logic in the choice of names. The name registration is an essential process before regulatory approval and marketing to avoid confusion with the names of established products.
Daewoong Pharm also said its entry into the U.S. botox market is on track with Nabota’s clinical data being reviewed by the Food and Drug Adminsitraiton (FDA).
Efforts to launch Nabota in the U.S. are being implemented gradually as the naming process is completed while the FDA’s approval process is underway, said Park Sung-soo, head of Nabota business at Daewoong Pharm.
At 3:00 p.m. Monday, shares of Daewoong Pharm were up 2.81 percent at 128,000 won ($115).
By Shin Chan-ok and Minu Kim
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