Perrigo Continues Overhaul Adding HRA Pharma, Boosts Chances For OTC Oral Contraceptive In US
HRA’s approval for pharmacy sales of a daily oral contraceptive the UK and its ongoing work on an NDA to propose making another progestin-only contraceptive ingredient available OTC in the US stand out as additions to Perrigo’s business with the most substantial revenue impacts.
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Cloud Over FDA Advisory Panel Meeting From ‘Over-Reporting’ In Birth Control OTC Switch Study
While HRA consultant says its study “meets or exceeds standards of most other studies assessing adherence, including an oral contraceptives,” FDA ONPD director says particpants’ over-reporting “is not something we see in a typical actual use study.”
US Oral Contraceptive OTC Switch Sponsor Says ‘Challenging Target’ Met For Adolescents In Study
HRA executives and other representatives for firm and FDA officials will make presentations about HRA’s sNDA to agency’s Nonprescription Drug and Obstetrics, Reproductive and Urologic Drugs advisory committees during a joint meeting on 9-10 May.
‘Over-Reporting’ An ‘Inherent Risk’ In Self-Report Study – Oral Contraceptive OTC Switch Sponsor
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.