For the first time, the Food and Drug Administration has approved a birth control pill that does not require a prescription.
The FDA announced Thursday it has approved Opill (norgestrel) tablets for over-the-counter use.
Opill was first approved in 1973 to prevent pregnancies but was taken off the market in 2005 due to business reasons.
Drugmaker Perrigo said it intends to have the drug available over the counter in early 2024.
"Today marks a truly momentous day for women's health nationwide," said Perrigo president and CEO Patrick Lockwood-Taylor. "Opill has the potential to radically transform women's access to contraception and is a true testament of Perrigo's unwavering commitment to deliver impactful solutions that truly make lives better.
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The FDA noted that of the 6.1 million pregnancies in the U.S. every year, half are unintended.
"Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes," the FDA said.
The FDA said Opill is up to 98% effective when used as directed. The FDA also said using additional forms of birth control, including condoms, helps make the drug more effective.
The agency said that real-world use, however, means the drug generally has lower effective rates as tablets aren't always taken when directed.
The FDA said side effects, such as irregular vaginal bleeding, nausea, breast tenderness and headaches, are generally mild and resolve on their own.
People who have or had breast cancer, are pregnant, using other forms of birth control, using emergency contraceptives or are male should not use Opill, the FDA said.
