Amneal Wins Race For US NuvaRing Rival
Immediately Started Commercialization Of Contraceptive
Amneal has become the first company to secure US approval for, and to launch, a generic alternative to Merck & Co’s top-selling, off-patent NuvaRing contraceptive device in the US. Other generics developers appear to be several months behind.
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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.
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.