Daewoong Pharmaceutical said it has recently obtained product approval for Nabota, a botulinum toxin (BTX) product, from the Saudi Arabian and Ukrainian governments.

Daewoong has obtained the sales approval of its BTX product Nabota in Saudi Arabia and Ukraine.
Daewoong has obtained the sales approval of its BTX product Nabota in Saudi Arabia and Ukraine.

Saudi Arabia is one of the largest markets in the Middle East in terms of population and economy, and the company plans to use the Saudi Arabian market as a bridgehead for full-scale sales expansion in the Middle East, according to Daewoong.

Ukraine is also a large Eastern European market, so the company expects the country to be a basis for Nabota's European market share expansion.

Daewoong has received approvals in various European countries other than EU member states as preparations for its full launch of Nabota in entire Europe this year.

The company has received approval for Nabota in 58 countries, including the U.S., Europe, and Canada. This year, it aims to increase the number to 100 countries, including China.

"Nabota is Asia's first BTX product that won the U.S. Food and Drug Administration’s approval, establishing itself as a global brand that has received approval in more than 50 countries," said Park Sung-soo, head of Daewoong's Nabota Business Division. "Through a successful launch in Europe scheduled this year, the company aims to enter more than 100 countries and make Nabota the top global BTX product."

Nabota is a BTX formulation launched in Korea in 2014. The product treats forehead and eye line wrinkles in the cosmetic field, upper extremity muscle stiffness, and eyelid spasms after stroke.

In April, Daewoong also applied to expand the indication for Nabota in treating square jaw to the Ministry of Food and Drug Safety. It conducts phase 2 clinical trials for chronic and episodic migraine and cervical tension through Aeon Biopharma, its U.S. partner.

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