FDA Schedules AdComm Review For First Over The Counter Birth Control Pill

The FDA has set a date to review what could become the first over-the-counter birth control pill approved in the U.S.
The regulatory agency scheduled a joint meeting of its Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee to review the application on November 18.
In July, the company submitted its application to the FDA for the first-ever over-the-counter (OTC) birth control pill, the first such request for this type of contraception.
The company previously announced that its affiliate, HRA Pharma, filed its application with the FDA for an Rx-to-OTC switch of Opill, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill).
Perrigo acquired HRA Pharma last year for $2.1 billion.
If approved, Opill has the potential to be the first-ever daily birth control pill available OTC without a prescription in the U.S.
Reuters reported, "While the review is moving quickly, FDA confirmed this is still within timelines of a standard review," a spokesperson for HRA said. Perrigo's unit had earlier said a period of about ten months is typical for such requests and that it was expecting a decision from the health regulator in the first half of 2023."
Price Action: PRGO shares closed at $40.69 on Monday.
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