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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American College of Obstetricians and Gynecologists proposed amending existing AMA policy in anticipation of Perrigo’s HRA business submitting NDA to FDA for OTC switch of progestin-only daily oral contraceptive the end of 2022.
Sponsors in both chambers amplify the FDA’s role announcing the legislation, saying the bills intend to “maintain the FDA’s sole authority to determine the safety and efficacy of drugs and make them available over-the-counter without a prescription.”
“We said we would start growing this company ... and this is the year to do it,” says CERO Murray Kessler. With nearly 11% net sales growth for its Americas business leading nearly 10% overall Q1 growth, Perrigo raises full-year guidance for net sales growth to 8% to 9%, up earlier 7% to 8%.