7 October 2021 - Mayne Pharma has received a complete response letter from the US FDA in relation to its abbreviated new drug application for a generic version of Nuvaring.
Mayne Pharma is working closely with its development partner, Mithra Pharmaceuticals and the FDA to address the questions raised in the complete response letter.
Following submission of the response to the complete response letter, Mayne Pharma will receive a new target action date from the FDA.