- Filing acceptance is a key regulatory milestone, confirming time line towards potential launch in the US by Mayne Pharma in H1 201
- Pending FDA approval, Mithra is eligible for down payment and milestone payments totaling at least EUR 10 million
- Mithra to produce Myring™ for Mayne Pharma at its CDMO, with substantial annual revenues expected
Liège, Belgium, 20 March 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is pleased to announce that the Abbreviated New Drug Application (ANDA) for its vaginal ring for contraception has been accepted for filing by the US Food and Drug Administration (FDA). The ANDA has been submitted by Mithra’s partner for the US commercialization of the vaginal ring, Mayne Pharma (ASX: MYX). The acceptance by the FDA is an important regulatory step, as it reconfirms the pathway towards launch of the product candidate in H1 2019.