On July 13, 2023, the FDA approved the first nonprescription progestin-only oral contraceptive pill in the US: https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive. PEGUS was pleased to have one of our senior consultants, Russell Bradford, MD, MSPH, participate in the 09-10 May 2023 FDA public advisory committee meeting for norgestrel tablet 0.075 mg. The committees voted unanimously (17 – 0) in favor of OTC availability.
We warmly congratulate the sponsor on this success, and enthusiastically endorse the approval of the progestin-only oral contraceptive pill as a new nonprescription product to address a critical unmet need in the US.
Presentations and other materials from the advisory committee meeting can be found here: https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-9-10-2023-joint-meeting-nonprescription-drugs-advisory-committee-and-obstetrics-reproductive-and#event-materials.
