US OTC Birth Control NDA Could Debut ‘Additional Conditions for Nonprescription Use’ Labeling

HRA didn't have time to incorporate into its switch NDA instructions stated in proposed ACNU rule published in June, but the firm, which worked with Ibis Reproductive Health on proposal, had time to plumb a draft guidance FDA published in 2018 on novel switches.

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A move US regulators acknowledged as a departure from the norm in their processes – publishing guidance before a rule – likely helped HRA Pharma prepare its new drug application for an OTC daily oral contraceptive.

The Perrigo Company PLC business submitted to the Food and Drug Administration its switch NDA for 0.075-mg norgestrel branded Opill two weeks after the agency published a proposed rule...

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