U.S. FDA to review Perrigo’s birth control pill for OTC use in November

Sept 12 (Reuters) – Perrigo Co. Plc (PRGO.N) 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.

The drugmaker’s unit, HRA Pharma, in July submitted an application to the health regulator seeking to make its prescription contraceptive drug, Opill, an over-the-counter pill. read more

Since the U.S. Supreme Court’s decision in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide, the spotlight has been on contraception access. read more

Abortion rights activists have stepped up calls to make mifepristone, which, in combination with misoprostol, induces an abortion up to 10 weeks into a pregnancy, available without a prescription. read more

Opill, a non-estrogen contraceptive, has been used with prescription since its approval in 1973. If the FDA approves HRA Pharma’s application, Opill would become the first daily OTC birth-control pill in the United States.

HRA said in July it was expecting a decision from the FDA in the first half of 2023.

Reporting by Bhanvi Satija in Bengaluru; Editing by Anil D’Silva

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Source: Reuters