Three Not A Magic Number For Mayne With Another NuvaRing CRL
Follows CRLs Handed Out By US FDA To Australian Firm In 2018 And 2020
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.
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Teva is keeping a keen eye out for opportunities like its US biosimilars agreement with Alvotech and more recent deal with Bioeq for biosimilar Lucentis as it attempts to maintain revenues in the coming years, following a cut to full-year sales guidance for 2021.
Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next 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.