Daewoong Pharmaceutical announced on August 16th that ‘Nabota’, a self-development botulism drug, received approval from Health Canada. Furthermore, Health Canada approved the sale of Nabota’s wrinkle treatment product.
‘Nabota’ is the first product among other Daewoong Pharmaceutical products to acquire approval for products from developing countries, and it has been evaluated that it is the first of Korea Botulinum toxin products to enter the Canadian market.
Daewoong Pharmaceutical filed a new drug approval application with Health Canada on July 31st last year, and obtained the GMP (Good Manufacturing Practice) certification to Daewoong’s Nabota production plant in May.
Daewoong Pharm is planning to launch its sales in Canada in the first half of next year and establish its position as a global brand in the North American market. Canada is a member of the seven leading G7 countries and is the fifth most advanced regulator of pharmaceutical regulation in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), after the United States, the European Union, Japan, and Switzerland.
DaewoongPharm’s partner, Evolus, will supply products to Canada through its partner Clarion Medical.
The company has more than 80 medical devices and more than 1,000 consumer health products, and has received he ‘2017 Private Business Growth Award’ given to companies that have achieved notable growth in Canada.
“The fact that the approval of the product was granted quickly in Canada within one year after the application for the license has an important meaning in terms of the quality, safety and efficacy of Nabota, which has been firmly proven in developing countries,” said Daewoong Pharm.
On the other hand, Daewoong Pharmaceutical is in the final stages of entering the U.S. market as it submitted supplementary data for Nabota’s U.S. marketing permit to the U.S. on August 2nd (local time). Furthermore, the approval process of the European Medicines Agency (EMA) is proceeding smoothly, and it is expected that it will be available in major developed countries such as the U.S. and Europe in the first half of next year.