Prasco Has Authorized Generic NuvaRing
Competes With Amneal’s Recently-Approved First US Generic
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.
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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.
In October, Dr Reddy’s Laboratories and ANI Pharmaceuticals are among companies expecting to hear from the US Food and Drug Administration for key applications, as the annual joint conference of Medicines for Europe and the International Generic and Biosimilar medicines Association takes place in Athens, Greece.