Mayne Knocked Back Again On US NuvaRing Rival
Pledges To Address Issues Raised In FDA Complete Response Letter
Mayne Pharma has received a further setback in its attempt to bring a generic version of NuvaRing to the US market after the FDA issued the firm with another complete response letter.
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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.
Recent Canadian, European and US endorsements of Mithra’s estetrol-based Estelle novel oral contraceptive mark a “turning point” for the Belgian firm, which has also seen success with its Myring generic rival to NuvaRing for which it expects to see further launches this year.
Teva has launched its generic version of NuvaRing in the US, adding a second rival generic to the market that already includes Amneal, as well as an authorized generic version from Prasco.