FDA advisers are slated to meet in early May to discuss whether the agency should approve an OTC oral contraceptive.
If approved, HRA Pharma’s Opill would be the first-ever daily birth control available OTC in the United States. Opill has been available with a prescription since its approval 50 years ago.
HRA Pharma submitted an application to switch from prescription to OTC status last July, and in October a previously scheduled FDA meeting was pushed back to review additional data requested by the company.