Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA have revealed that the US Food and Drug Administration (FDA) has granted approval of the Abbreviated New Drug Application (ANDA) for HALOETTE vaginal hormonal contraceptive ring.
Mayne Pharma anticipates the commercial launch of HALOETTE ring by early calendar year 2023.
HALOETTE contraceptive is a generic version of NUVARING, a combined hormonal contraceptive flexible ring that combines etonogestrel and ethinyl estradiol and is indicated for the prevention of pregnancy.
According to IQVIA, NUVARING US brand and generic sales were approximately US$580 million for the 12 months ended June 2022.
Under the terms of the long-term license and supply agreement, Mayne Pharma will pay Mithra EUR6 million as a result of receiving FDA approval and EUR1.6 million upon commercial launch in the US. Mithra will manufacture HALOETTE at its contract development and manufacturing organisation (CDMO) facility in Belgium.
We are very pleased to announce the approval of HALOETTE in the US and look forward to bringing this drug-device generic to market,” Mayne Pharma’s CEO, Scott Richards, said.
“Mayne Pharma is proudly committed to providing women with more affordable and accessible contraceptive choices. After the approval of NEXTSTELLIS oral contraceptive in the US and Australia, this marks the third regulatory product approval we have received with Mithra as our development partner.”