Dae­woong’s BTX re­ceives nod from Health Canada

BioSpectrum (Asia) - - REGULATORY NEWS -

Korea’s Dae­woong Phar­ma­ceu­ti­cal 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 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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