Mithra Pharmaceuticals S A : Provides FDA Update on Myring®

Liege, Belgium, 6 October 2021 - 17:45 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 (CRL) from the US Food and Drug Administration (FDA) in relation to the abbreviated new drug application (ANDA) for Myring®, the vaginal contraceptive ring made of ethylene vinyl acetate copolymers (EVA).

In the letter, Mayne Pharma has been requested to provide additional data on compatibility. All other topics, in particular the manufacturing process by the Mithra CDMO, did not raise any supplementary questions. Mayne Pharma is working closely with Mithra and the FDA to address the few remaining questions raised in the CRL before year-end.