Galderma says FDA issues complete response letter for RelabotulinumtoxinA BLA over manufacturing inspection findings

  • Galderma received an FDA Complete Response Letter for its U.S. BLA for RelabotulinumtoxinA, delaying potential approval.
  • FDA cited observations from a pre-license inspection at a manufacturing site, citing manufacturing controls and analytical method optimization.
  • Safety and efficacy sections of the filing raised no deficiencies.
  • Corrective and preventive actions are underway; the company plans a rapid response while continuing discussions with the FDA.
  • Issue is not expected to affect approvals or launches in other markets; Relfydess is approved in 33 markets, launched in more than 20.


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