Perrigo unit submits approval application to FDA for OTC birth control pill

[July 11, 2022]  (Reuters) - Perrigo Company said on Monday its unit has submitted an application to the U.S. Food and Drug Administration (FDA) for approval of an over-the-counter (OTC) birth control pill.

The application from the Paris-based HRA Pharma comes on the back of the U.S. Supreme Court's decision in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide.

If approved, the contraceptive, which is currently a prescription drug under the brand Opill, would be the first daily birth control pill available without a prescription in the U.S., the company said.

The non-estrogen pill has been used with prescription since it was FDA-approved in 1973. Perrigo said scientific evidence has shown progestin-only pills like Opill are effective at preventing pregnancy and safe for most women to use.

Birds are seen on the logo of generic drugmaker Perrigo Co outside their new factory in the city of Yeruham, in southern Israel March 2, 2016. REUTERS/Amir Cohen

The conservative-leaning U.S. Supreme Court's decision last month curbing the right to an abortion has shifted the focus to alternatives.

Abortion rights activists have stepped up calls to make mifepristone, which in combination with a second drug called misoprostol induces an abortion up to 10 weeks into a pregnancy, available OTC.

(Reporting by Leroy Leo in Bengaluru; Editing by Krishna Chandra Eluri)

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