FDA 2023 round-up: Top headlines of the year

12 December 2023

In 2023, the number of drugs approved by the US Food and Drug Administration (FDA) rose, following a sparse year in 2022. The past year saw the agency return to the same pace it had achieved from 2017 to 2021. In 2022, the FDA approved only 37 new drugs, but reached 50 approvals by the middle of November, 2023.1

Over-the-counter approvals

One of the big headlines this year was the approval of an over-the-counter birth control pill. Opill (norgestrel; from Laboratoire HRA Pharma, recently acquired by Perrigo) that was first approved by the FDA as a prescription oral contraceptive in 1973. In July, 2023 - fifty years later—came the approval of Opill, a version that does not require a prescription.1

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