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

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  • 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.
  • Photo by Thomas Breher from Pixabay
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