After failure to close of a potential $177m buyout by EW Pharma, TherapeuticsMD will resolve its debt by selling its three-product women’s health portfolio to Mayne.

Following a trio of complete response letters received since late 2018, Mayne Pharma and partner Mithra Pharmaceuticals have finally obtained US FDA approval for a generic version of Organon’s NuvaRing vaginal hormonal contraceptive ring.

Mayne Pharma and Mithra have revealed launch plans in Australia for their Nextstellis oral contraceptive that combines the novel estrogen estetrol with drospirenone, following approval by the TGA.

Australia’s Mayne Pharma has announced another complete response letter for its proposed generic version of Organon’s NuvaRing (etonogestrel/ethinylestradiol) contraceptive device, marking a trio of setbacks for the ANDA product.