Mayne And Mithra Obtain Long-Awaited NuvaRing Nod From FDA
Haloette Will Be One Of Three Generics In US Market, Alongside Amneal And Teva
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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Mayne Pharma has expressed confidence after its recent US launch of Nextstellis (estetrol/drospirenone) 14.2mg/3mg oral contraceptive tablets. While the firm’s overall sales dipped by 6% in its financial first half, Mayne expects its recent and near-term launches, particularly key dermatology products, to help reverse the trend.
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 launched an authorized generic version of NuvaRing in the US, hot on the heels of Amneal’s launch of the first FDA-approved generic.