But the FDA notes that half of women in Perrigo’s study who had unexplained bleeding incorrectly said Opill would be appropriate for them. And women who have unusual vaginal bleeding are instructed to talk to a doctor first, because it could indicate a medical problem. Women with a history of breast cancer should not take the pill, though a few participants in preliminary research incorrectly said they thought they could. The FDA review also flagged concerns that women with potential health problems will appropriately avoid taking the drug. but is sold without a prescription in the U.K. Perrigo acquired rights to the drug last year with its buyout of Paris-based HRA Pharma, which bought the pill from Pfizer in 2014. Hormone-based pills, like Opill, have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Research for over-the-counter sales of the pill began nearly a decade ago. The company’s application has no relation to the ongoing lawsuits over the abortion pill mifepristone, which is not a contraceptive. “We have no doubt that our data clearly shows that women of all ages can safely use Opill in the over-the-counter setting,” Frederique Welgryn, the company’s global vice president for women’s health, said this week. women - or one-fifth of those who are child-bearing age - who currently use no birth control or less effective methods, such as condoms. Perrigo executives say Opill could be an important new option for the estimated 15 million U.S. South Korean, German leaders agree to cooperate on supply chains, North Korea
0 kommentar(er)
