Approvals

The US Food and Drug Administration (FDA) has announced that it has approved the Opill (norgestrel) tablet for non-prescription use to prevent pregnancy. This approval makes Opill the first daily oral contraceptive approved for use in the US without a prescription, meaning it will be available over the counter (OTC) at pharmacies, supermarkets and other stores, as well as online.

The efficacy of the drug was established in 1973 when norgestrel was approved for prescription use, however HRA Pharma has applied to switch this to an OTC product. For an OTC approval, the FDA requires proof that the product can be used by consumers safely and effectively, relying only on the non-prescription drug labelling. Studies showed that consumer understanding was high overall for Opill.

Common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps and bloating.

Patrizia Cavazzoni MD, director of the FDA’s Center for Drug Evaluation and Research, commented: “Today’s approval marks the first time a non-prescription daily oral contraceptive will be an available option for millions of people in the United States. When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy.”

This approval is intended to reduce barriers to access by allowing individuals to access contraceptives without needing to see their healthcare providers first.