Tag Archive for: over the counter

An unmet need in the contraceptive field is availability and access for patients. Almost half of the 6.1 million pregnancies in the United States annually are unintended, so the approval of Opill to be sold over the counter without a prescription allows increased accessibility, promoting timely use and reducing barriers to family planning, according to GlobalData.

The daily contraceptive Opill, sold by Perrigo, was first approved for prescription use in 1973, and the over-the-counter approval clears the way for people to obtain it without first seeing a healthcare provider.

This test is the first at-home over-the-counter (OTC) test for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness.

The joint committee of external experts voted unanimously in favor of Perrigo, finding that the benefits of allowing non-prescription use of the birth control tablet Opill outweigh its risks.

The U.S. health regulator’s reviewers on Friday raised concerns around allowing Perrigo Co’s birth control drug over the counter, saying switching to non-prescription sale could lead to inappropriate usage by consumers.

The panel will decide on recommending the non-estrogen contraceptive as a daily OTC birth control pill on May 9 and 10. The drug, Opill, is expected to be the first such pill in the United States if approved.

The U.S. Food and Drug Administration has delayed a meeting of its advisory panel to discuss Perrigo Co. Plc’s over-the-counter (OTC) contraceptive, the drugmaker said on Wednesday.

Major U.S. retailers will begin selling lower-cost hearing aids without a prescription or medical exam under final Biden administration rules that take effect Monday.

Perrigo Company said on Monday its HRA Pharma unit has asked the U.S. Food and Drug Administration (FDA) to approve a daily birth control pill for over-the-counter (OTC) sale, the first such request for this type of contraception. HRA Pharma expects the regulator to hold an advisory committee meeting and approve the application in the first half of 2023, which is typical for such requests, said Frédérique Welgryn, HRA Pharma’s chief strategic operations and innovation officer.