• 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).

Attachments

  • Original document
  • Permalink

Disclaimer

Mithra Pharmaceuticals SA published this content on 06 October 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 October 2020 05:34:05 UTC