South Korea’s Daewoong Pharmaceutical on Friday said that no fake copies of its botulinum toxin Nabota were circulated in South Korea, addressing public fears that the inauthentic drugs may have been sold and administered to local patients.

The company’s investigation came after the local police caught two groups of vendors developing and selling fake copies of Nabota in China. The news prompted Korea’s Ministry of Food and Drug Safety to issue a warning last week to local hospitals to beware of counterfeit copies of Daewoong’s anti-wrinkle treatment.

Though Korean investigators said they did not find any fake copies of Nabota that were circulated in Korea, Daewoong recently decided to mobilize its own staff to strengthen its quality assurance and to ease growing public worries.

“Daewoong directly sells all of its products to clients, and thus they are confident that no fake copies of Nabota could have been sold in Korea,” a Daewoong Pharmaceutical official said. “Nonetheless, we’re working to double-check our product circulation to ensure the safety of our patients.”

The fake Nabota issue emerges at a sensitive time for Daewoong Pharmaceutical, which is seeking to submit its anti-wrinkle treatment to the US Food and Drug Administration for approval, by as early as this month.

Daewoong, together with its US and Europe marketing and distribution partner Alphaeon Corp., are preparing to submit a biologics license application for DWP-450, another label for Nabota, to the FDA .

If approved by the US regulator, Nabota would become the first ever Korea-made botulinum toxin to hit the US market.

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