Estaderma
FDA issued a warning letter to Estaderma, a South Korea-based company operating www.estaderma.com, for selling unapproved and misbranded injectable botulinum toxin products ('Liztox 100u' and 'Liztox') to U.S. consumers without FDA approval under section 505 of the FD&C Act. The products were marketed with treatment claims for hyperhidrosis and were found to lack adequate directions for use as required for prescription drugs. FDA warned that failure to cease distribution may result in seizure or injunction, and required a written response within 15 working days.
Flagged claims (2)
provide a treatment (at hyperhydrosis) pointwise, without any side effects on the whole body.
Liztox may be used for the treatment of increased diaphoresis via injections at the perspiratory gland localization (palms, axillas, footsteps)
Required actions (3)
FDA requests that www.estaderma.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice.
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