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 raised in the CRL,” without providing any further specific detail....
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