AMA Shares OTC Birth Control Diagnosis With FDA
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.
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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.”
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.
The UK's MHRA has approved the Rx-to-OTC switch of two identical progestogen-only contraceptive pills from HRA Pharma and Maxwellia. Hana and Lovima (both 75mcg desogestrel) will be launched at the end of the month.