Mithra Announces FDA update

  • Mithra’s US partner Mayne Pharma receives complete response letter from FDA for Myring™ requesting additional data that is not normally requested for generic products
  • Based on the information available to date, Mithra expects to have the necessary data in hand to respond to FDA before year-end
  • No questions or comments have been raised by FDA with regard to Mithra CDMO, which provides comfort regarding robustness of manufacturing process
  • Mid-cycle review with FDA regarding the New Drug Application (NDA) for Estelle (Nextstellis) raised no substantive issues
  • Solid cash position and funding facilities to cover working capital needs

Liege, Belgium, 6 October 2020 – 07:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that its US commercial partner Mayne Pharma (ASX: MYX)  has received a Complete Response Letter from the US Food & Drug Administration (FDA) related to the abbreviated new drug application (ANDA) for Myring™, the vaginal ring made of ethylene vinyl acetate copolymers (EVA).