Home China Daewoong Enters P3 Trial for Nabota in China

Daewoong Enters P3 Trial for Nabota in China

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China Derm

Korea Biomedical Review reports Daewoong Pharmaceutical received approval from China Food and Drug Administration (CFDA) for its phase 3 clinical trial into nabota, its botulinum toxin.  The industry sponsor had to refile its clinical trial application (CTA) with an update in production site from its first plan to second one in December. Now that the Chinese authorities have given the green light, the industry sponsor will test Nabota to treat forehead wrinkles in China.  Nabota became the first local BTX to acquire sale approval from the FDA in February. The company is also seeking approval in the U.S. and EMA.

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