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Daewoong prepares to enter US market with botulinum toxin
  • By Constance Williams
  • Published 2017.11.06 13:29
  • Updated 2017.11.06 13:29
  • comments 0

Daewoong Pharmaceuticals said Monday the company has registered its botulinum toxin (BTX) strain “Nabota” as a pharmaceutical ingredient in the U.S. under the name of "Prabotulinum toxin A."

The U.S. Adopted Name (USAN) is one of the international pharmaceutical ingredient names, officially designated by the American Medical Association (AMA).

USAN is essential for winning the approval for selling medicines in the United States, to prevent confusion with the existing drugs in prescribing new drugs. They adopt different ingredient names in recognition of the unique characteristics of botulinum toxin preparations.

In general, USAN is registered for reference instead of a drug’s code name, but it is selected through scientific and trademark reviews with its global use in mind.

"Nabota's entry into the U.S. market is being made gradually with the USAN registration and FDA's full-scale license screening,” said Park Sung-soo박성수, a business manager for Nobata. "Prabotulinumtoxin A, the ingredient name that can represent the brand of Nabota as effectively as its brand name, will be used in the global pharmaceutical market.”

connie@docdocdoc.co.kr

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