Mayne Pharma and Mithra Announce FDA Approval of HLOETTE®, a Generic Version of NUVARING® – 08/08/2022 at 07:30


August 08, 2022, 07:30 CEST – Adelaide, Australia and Liège, Belgium – Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are pleased to announce that the Food and Drug Administration ( US FDA) has approved the Abbreviated New Drug Application (ANDA) for the HALOETTE® vaginal contraceptive ring (etonogestrel and ethinyl estradiol). Mayne Pharma expects the commercial launch of the HALOETTE® ring in early 2023.

The HALOETTE® contraceptive is a generic version of NUVARING®, a combined flexible hormonal contraceptive ring combining etonogestrel and ethinyl estradiol and indicated for the prevention of pregnancy.



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