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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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.
Mayne Pharma and Mithra have revealed launch plans in Australia for their Nextstellis oral contraceptive that combines the novel estrogen estetrol with drospirenone, following approval by the TGA.
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.