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THE INVESTOR

Bio & Medicine

Daewoong gets US approval for generic name of Nabota

  • PUBLISHED :November 06, 2017 - 15:16
  • UPDATED :November 06, 2017 - 15:16
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[THE INVESTOR] Korea’s drug maker Daewoong Pharmaceuticals said Nov. 6 the United States Adopted Names Council has approved the non-proprietary name Prabotulinumtoxin A for its self-developed botulinum toxin Nabota, a step closer to its commercial launch in the country.

With the approval, Prabotulinumtoxin A is now the generic name and the green light from the USAN, which is responsible for naming all generic drugs, enables Nabota to avoid getting confused with existing treatments. It is mandatory for the firm to receive marketing approval from the US Food and Drug Administration. 



“Nabota’s market entry into the US is being phased in with the registration, following FDA’s full-scale license screening,” said Park Sung-soo, business manager of Nobata.

In May, Daewoong’s US distribution partner Alphaeon submitted a biologic license application for the drug with the US regulator seeking approval for the treatment of adult patients with frown lines.

Daewoong is hoping to begin shipping Nabota in the second half of 2018 after receiving the FDA’s Current Good Manufacturing Practices certification for its new plant, located in Hyangnam, Gyeonggi Province, that will produce the wrinkle treatment.

By Park Han-na (hnpark@heraldcorp.com
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