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Mayne And Mithra Obtain Long-Awaited NuvaRing Nod From FDA

Haloette Will Be One Of Three Generics In US Market, Alongside Amneal And Teva

Executive Summary

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.

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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.

Prasco Has Authorized Generic NuvaRing

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