Hugel's Letybo benefits from FDA delay of Revance's DAXI
By Nho, Byung Chul | translator Alice Kang
21.10.18 06:19:00
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FDA points to DAXI's lack of working cell bank verification etc. as issues of concern
US launch of the new botulinum toxin company, Revance, is at stake
Its competitor Hugel’s approval in smooth progress… expectations rise on the sales of the local toxin ‘Letybo’ in the US
The U.S. Food and Drug Administration’s disclosure of the official document outlining concerns in the DAXI manufacturing plant of the botulinum toxin company, Revance Therapeutics (hereinafter ‘Revance’), raised industry concerns about the uncertainty of the company’s approval.
Revance is a new medical aesthetics company that sells botulinum toxin and HA filler products. The company had submitted a Biologic License Application to the FDA for its botulinum toxin product DAXI in 2020 and expected to receive marketing authorization by 2021.
The FDA conducted an on-site inspection of the company's manufacturing plant from late June to early July. The document that was disclosed t
Nho, Byung Chul(sasiman@dailypharm.com)
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