Daewoong Pharmaceutical said Monday that it has received sales approval for Nabota, its botulinum toxin (BTX) product to treat forehead wrinkles, from Health Canada.
Nabota became the first product initially developed by Daewoong to acquire sales approval from an advanced country. The treatment is also the first Korean BTX product to enter the Canadian market.
Daewoong filed for approval with the Canadian health authorities on July 31 last year, while obtaining GMP approval for its Nabota plant in May.
The company plans to begin sales in Canada in the first half of next year and establish its position as a global brand in the North American market. Evolus, Daewoong’s U.S. partner, will supply products through Clarion Medical. Canada, a G7 member, is the fifth country to register at the International Commission on the Regulation of Medicines (ICH), after the U.S., EU, Japan, and Switzerland.
“The approval in Canada within a year of the application is significant as it proves the high quality, safety and efficacy of Nabota from a pharmaceutically advanced nation,” said Park Sung-soo, head of Daewoong’s Nabota business division. “With the approval from Canada, We plan to expand to North America, which is the largest BTX market in the world.”
Daewoong has entered the final stage of its entry into the U.S. market by submitting additional data to the Food and Drug Administration (FDA) on May 2. Also, its approval process for the European Medicines Agency (EMA) is proceeding smoothly.
The company expects to receive sales approval in major developed countries such as the U.S. and EU by the first half of next year.
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