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.
You may also be interested in...
Mayne And Mithra Add Further US NuvaRing Rival
Mayne Pharma and partner Mithra have announced the launch of their Haloette generic version of NuvaRing in the US, adding further competition to a field that already includes Amneal and Teva as well as Prasco’s authorized generic.
Mayne Banks On Nextstellis As Generics Business Suffers
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 And Mithra Receive Australian Nextstellis Approval
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.