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.
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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.
Under a federal judge’s order, FDA must reverse its denial of the Center for Reproductive Rights’ 12-year-old citizen petition and allow universal OTC access to Plan B One-Step and equivalent levonorgestrel-based emergency contraceptives within 30 days.
The court ruling overturning FDA's restricted distribution of the emergency contraceptive Plan B could have a number of implications for the biopharma industry - ranging from a near-term impact on confirmation of Obama administration nominees to a longer-term curbing of creative product risk management activities