The FDA asked Mayne and Mithra for additional bioequivalence data in comparison to Nuvaring. From what I have read, it looks like the FDA now have 2 months to respond again to Mayne, either with approval, additional questions or rejection. Anything is possible, but my strong assumption is that Mayne will have provided all of the necessary information and the FDA will approve. Time will tell.
New Product Approvals, page-36
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