On July 13, the FDA approved an oral contraceptive pill called Opill to be sold over the counter, making it a first in the U.S.
To obtain OTC status, the drug's manufacturer HRA Pharma, which was recently acquired by Perrigo, had to demonstrate that the medication "can be used by consumers safely and effectively" without assistance from healthcare professionals, according to the FDA. HRA Pharma first applied for prescription-free status last July.
The drugmaker anticipates the progestin-only tablet (norgestrel) will be available in stores and online without a prescription in early 2024. Details on pricing have not yet been shared.
"Today marks an important step in the drive toward meaningful access to essential healthcare for Americans," HHS secretary Xavier Becerra said in a statement. "The FDA's approval of the first daily over-the-counter oral contraceptive will provide millions with access to safe and effective birth control without a prescription. For women, this approval will lower longstanding barriers to the healthcare they need."