Canada approves Daewoong Pharmaceutical’s BTX Nabota

South Korea’s Daewoong Pharmaceutical said Monday that Health Canada had granted marketing approval for its type A botulinum toxin drug Nabota, clearing the way for the product’s launch in North America.

Nabota has been approved by the Canadian drug regulator for the treatment of wrinkles in the forehead, according to the drugmaker. It is the first of Daewoong’s self-developed drugs to be approved for sales in a major global pharmaceutical market.

The regulatory clearance comes three months after Health Canada granted Good Manufacturing Practice certification to Daewoong’s Nabota production plant here in May.

Looking ahead, Daewoong plans to start selling Nabota in Canada within the first half of next year, via Clarion Medical, a partner of Evolus, which has struck a marketing partnership with Daewoong for the US, Canada, Europe and Australia.

In addition to Canada, Daewoong is also drawing closer to obtaining regulatory approval for Nabota in the US. Earlier this month, the company filed supplementary data for Nabota, after the US Food and Drug Administration had initially rejected the drug, citing deficiencies in the drug’s manufacturing process.

With Nabota approval documents conclusively submitted for the US FDA, together with an ongoing review by the European Medicines Agency, Daewoong said it expects to start selling Nabota in the US and Europe within the first half of this year.

By Sohn Ji-young (jys@heraldcorp.com)