Over the counter birth control approved by the FDA
Over the counter birth control approved by the FDA

HRA Pharma expects the FDA to make a final decision this summer on an over-the-counter application for its Opil, commonly known as norgestrel.

Source: dog

U.S. Food and Drug Administration Thursday officially recognized The first over-the-counter birth control pill, a landmark decision that will enable more American women and girls to prevent unwanted pregnancies without prescription.

The daily pill, called Opil, is the first officially recognized It was listed as a prescription drug by FDA in 1973.

The pill’s maker, Paris-based HRA Pharma, said the contraceptive would likely be available in pharmacies, convenience stores, grocery stores and online retailers in the U.S. by early 2024.

HRA Pharma, a subsidiary of the Dublin-based pharmaceutical company PerigoThere will be no age restrictions on the sale of the drug, the company said.

HRA Pharma has not released a price for the drug, which will determine public affordability. But Frederique Welgryn, Perrigo’s global vice president of women’s health, said in a statement that the company is committed to making the drug “available and affordable to women and people of all ages.” .

Shares of Perrigo rose 5% in early trading Thursday following the news.

Opil could significantly expand contraceptive access, especially for young women and women in rural and underserved communities who often struggle to conceive.

The approval of the drug is a victory for the Biden administration, which has been trying to strengthen reproductive rights as restrictions on abortion have increased in many states.

The Supreme Court’s decision to overturn the landmark Roe v. Wade decision more than a year ago — which ended 50 years of federal abortion rights — led to a nationwide decline in abortion procedures and renewed calls for expanded birth control range.

“Today’s approval is a breakthrough expansion for American women’s health and an important milestone in addressing the critical unmet need for contraceptives,” Wellgreen said in a statement.

Oral contraceptives have long been the most common form of birth control in the United States, used by tens of millions of women since the 1960s. But so far, all of them require a prescription.

medical institutions such as American College of Obstetricians and Gynecologists Women’s health advocates have been pushing for wider access.

more than 50 members Congress In March 2022, also called on FDA Commissioner Dr. Robert Califf to ensure the agency promptly reviews applications for over-the-counter birth control pills.

Of the 6 million pregnancies a year in the United States, an estimated 45 percent are unintended, the groups note.

Unplanned pregnancies are associated with negative outcomes, including a reduced likelihood of receiving early prenatal care and an increased risk of preterm birth, the FDA said. These complications are also associated with poor developmental and child health outcomes, the agency said.

Daily oral contraceptives are safe and “expected to be more effective than current birth control pills,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a release.
Over-the-counter birth control methods to prevent unwanted pregnancy. “

Other over-the-counter methods include condoms and spermicide.

Opil was found to be 93% effective in preventing pregnancy, with prescription oral contraceptives.

This birth control pill contains a hormone called progesterone, which thickens cervical mucus and prevents sperm from reaching and fertilizing an egg, preventing pregnancy.

FDA scientists in May raised concerns about whether women who have or have had breast cancer know not to use the drug. Progesterone increases the risk of breast cancer recurrence.

The agency’s scientists also worry about whether some women who experience unexplained vaginal bleeding between menstrual cycles will know not to take Opil before consulting their doctors.

But in the end, an FDA advisory panel agreed that most women can decide for themselves whether the drug is right for them.

The group also voted unanimously to recommend that Opil be offered without a prescription.


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