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Drug company asks FDA to approve over-the-counter contraceptive pill

BMJ 2022; 378 doi: (Published 12 July 2022) Cite this as: BMJ 2022;378:o1727
  1. Janice Hopkins Tanne
  1. New York

The French drug company HRA Pharma has asked the US Food and Drug Administration to approve switching the progestin-only oral contraceptive Opill from prescription to over-the-counter use.1

HRA is a subsidiary of Perrigo, which makes several over-the-counter medicines.

The US application on 11 July came a year after the UK’s Medicines and Healthcare Products Regulatory Agency authorised reclassification of the company’s oral contraceptive Hana from prescription only to being available over the counter with a pharmacist consultation. Hana, which contains 75 micrograms (0.075 mg) of desogestrel, was one of two oral contraceptives authorised for use over the counter in …

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