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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

 
• By Dean Rudge

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.

Three Fingers Hand Sky
Mayne has received a third CRL over its NuvaRing rival • Source: Alamy

Mayne Pharma’s proposed generic version of Organon’s NuvaRing (etonogestrel/ethinylestradiol) contraceptive device in the US is proving to be something of an albatross for the company, with the US Food and Drug Administration once again issuing a complete response letter detailing that it cannot approve the firm’s application in its current form.

The Australian firm said it was “working closely with its development partner, Mithra, and the FDA to address the questions...

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