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‘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'

Executive Summary

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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Adolescent Access Weighs Heavy In US FDA Decision On First OTC Daily Oral Contraceptive

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.

US FDA Requests More Information, Needs More Time To Review Birth Control OTC Switch Proposal

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.

US FDA Has 10 Months To Provide Answer On Perrigo/HRA OTC Oral Contraceptive Application

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. 

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