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FDA Approves First-In-Class OTC Contraceptive!

By July 13, 2023February 22nd, 2024No Comments

On July 13, 2023, the FDA approved the first nonprescription progestin-only oral contraceptive pill in the US: 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: