NABOTA INJ.

“First Korea-made Botulinum Toxin to obtain the US FDA approval”

NABOTA is the first Korea-made botulinum toxin that has been approved by the US FDA for the treatment of frown lines as of February 1^st, 2019. 

NABOTA was developed by the ‘High-pure Technology’ to reduce the alien matters for higher purity. In Korea, it 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 factory 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.

[Composition]

²  Active ingredient: Clostridium botulinum toxin type A

²  Stabilizer: Human serum albumin 0.5mg

²  Isotonic agent: Sodium chloride (USP) 0.9mg

[Description]

²  White to yellowish, vacuum-dried powder for injection in a transparent vial

²  Colorless transparent liquid after dissolution the diluent

[Main Characteristics of NABOTA]

1)     Patented Technology: Patent related to purification process registered (KR 10-1339349)

2)     Reduced Impurity: Highly purified product through patented purification process to remove impurities to the maximum

3)     Proven Efficacy & Safety: Clinical studies with Botox of Allergan as reference drug product

²  NABOTA shows a rapid onset of improvement effects in glabella lines

²  NABOTA is effective in improving glabella lines

²  NABOTA did not form antibody in Phase III clinical studies

[Storage Condition & Shelf-life]

²  Storage: NABOTA should be stored in a freezer(below -5℃) or refrigerator(2~8℃)

²  Shelf-life: 36 months from the manufacturing date