Tag Archive for: Opill

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.

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 FDA is kicking off May with three target action dates and three advisory committee meetings, including one for a high-profile investigational gene therapy.

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.

Perrigo Co. Plc said on Monday that the U.S. Food and Drug Administration had scheduled a meeting of external experts on Nov. 18 to review the application of its daily birth control pill for over-the-counter (OTC) use.

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.