FDA Approves Haloette Vaginal Hormonal Contraceptive Ring

The Food and Drug Administration (FDA) has approved Mayne Pharma and Mithra’s abbreviated New Drug Application (ANDA) for Haloette^®, a generic version of Nuvaring^®, for use by females of reproductive age to prevent pregnancy.

The contraceptive vaginal ring releases on average 0.12mg/day of etonogestrel, a progestin, and 0.015mg/day of ethinyl estradiol, an estrogen, over a 3-week period of use. The ring is removed for a 1-week break, during which a withdrawal bleed usually occurs. A new ring is inserted 1 week after the last ring was removed. 

Haloette is expected to be available by early 2023.

Mayne Pharma’s CEO Scott Richards said, “We are very pleased to announce the approval of Haloette^® in the US and look forward to bringing this drug-device generic to market.”

Reference

Mayne Pharma and Mithra announce FDA approval of Haloette^®, a generic version of Nuvaring^®. News release. Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA. Accessed August 9, 2022. https://www.maynepharma.com/wp-content/uploads/2022/08/Mayne-Pharma-and-Mithra-announce-FDA-approval-of-Haloette-a-generic-version-of-Nuvaring.pdf