‘Over-Reporting’ An ‘Inherent Risk’ In Self-Report Study – Oral Contraceptive OTC Switch Sponsor
HRA Says Results Supporting Safe OTC Not Affected While Cause ‘Incompletely Understood'
HRA says its research in support of its sNDA for its 0.75-mg norgestrel tablet branded Opill shows accurate OTC self-selection and safe use of the progestin-only drug by females of reproductive age.
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FDA asks its Nonprescription Drug and Obstetrics, Reproductive and Urologic Drugs advisory committees during a joint meeting on 9-10 May to recommend whether to approve HRA Pharma’s proposal for OTC switch of a daily oral contraceptive, its 0.075-mg norgestrel tablet branded Opill.
FDA decision on Perrigo subsidiary’s proposal for first US OTC daily oral contraceptive is extended 90 days with the postponement of an advisory panel meeting. Agency requested additional information related to OTC switch application of 0.075-mg norgestrel initially submitted in July.
Perrigo's HRA Pharma submits to FDA on 11 July an NDA by for OTC 0.075-mg norgestrel, branded Opill, The same formulation previously was available Rx 30 years.