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HRA Pharma expects a final decision by the FDA this summer on its application for over-the-counter sales of Opill, generically called Norgestrel.
Source: Dog
Food and Drug Administration on Thursday consent The first over-the-counter birth control pill, a landmark decision that will allow more women and girls in the United States to prevent unwanted pregnancies without a prescription.
The daily pill, called Opill, was the first consent by the Food and Drug Administration (FDA) as a prescription in 1973.
Paris-based pill manufacturer HRA Pharma said the contraceptive will likely be available in stores and online retailers in the United States in early 2024.
HRA Pharma, a unit of a Dublin-based pharmaceutical company PeregoThere will be no age restrictions on birth control pill sales.
HRA Pharma has not announced the price of the pill, which will determine its public availability. But Frederick Welgren, global vice president of women’s health for Perrigo, said in a statement that the company is committed to making birth control pills “accessible and affordable to women and people of all ages.”
Perrigo’s share price jumped 5% in early trading Thursday after the announcement.
Opel can greatly expand access to contraceptives, especially for younger women and those in rural and underserved communities who often have difficulty obtaining contraceptives.
“Today’s approval marks a groundbreaking expansion for women’s health in the United States, and a significant milestone toward addressing the key unmet need for access to contraceptives,” Welgren said.
Oral contraceptives have long been the most popular form of birth control in the United States, and have been used by tens of millions of women since the 1960s. But as of now, all of them require a prescription.
medical organizations such as American College of Obstetricians and Gynecologists Women’s health advocates have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the United States are unintended.
These pregnancies have been linked to negative outcomes, including a decreased likelihood of receiving early prenatal care and an increased risk of premature delivery, according to the Food and Drug Administration. The agency said that these complications are also associated with negative outcomes for the development and health of the child.
Daily oral contraceptives are safe and “expected to be more effective than what is currently available,” said Dr. Patricia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
Over-the-counter contraceptives in preventing unwanted pregnancy.
Other over-the-counter methods include condoms and spermicide.
Opill has been found to be 93% effective in preventing pregnancy, similar to Oral contraceptives.
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