Mithra Pharmaceuticals SA

08/08/2022 | Press release | Distributed by Public on 08/07/2022 23:34

Mayne Pharma and Mithra announce FDA approval of HALOETTE®, a generic version of NUVARING®

8 August 2022, 07:30, Adelaide, Australia and Liege, Belgium - Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are pleased to announce that the US Food and Drug Administration (FDA) has granted approval of the Abbreviated New Drug Application (ANDA) for HALOETTE® (etonogestrel and ethinyl estradiol) vaginal hormonal contraceptive ring. Mayne Pharma anticipates the commercial launch of HALOETTE® ring by early calendar year 2023.