Perrigo unit asks FDA to approve first ever over-the-counter birth control pill

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A pharmacist holds the compound PiDaNa of the corporate HRA Pharma in Hamburg, Germany.

Daniel Reinhardt | Image Alliance | Getty Photos

Perrigo Company stated on Monday its unit HRA Pharma has requested the U.S. Meals and Drug Administration to approve a each day contraception tablet for over-the-counter sale, the primary such request for the sort of contraception. The applying from the HRA comes on the again of the U.S. Supreme Courtroom’s choice in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide.

The contraceptive is at present a prescription drug offered below model Opill.

HRA Pharma expects the regulator to carry an advisory committee assembly and approve the appliance within the first half of 2023, a interval of about 10 months is typical for such approval requests, stated Frédérique Welgryn, HRA Pharma’s chief strategic operations and innovation officer.

“The timing is a bit coincidental. We have now been engaged on that software for the final seven years,” Welgryn stated.

The FDA declined to touch upon the submission.

In the meantime, Iffath Abbasi Hoskins, president of the American School of Obstetricians and Gynecologists, stated the submission was a constructive.

“We all know that contraception just isn’t an answer to abortion bans, as folks want abortion care for a lot of causes,” Hoskins stated, however added that the tablet may nonetheless assist extra folks to “management their very own reproductive futures”.

Presently, the one contraception medicine accessible for ladies with no prescription are emergency oral drugs that may be taken inside three days after having unprotected intercourse.

Abortion rights activists have stepped up calls to make mifepristone, which together with misoprostol induces an abortion as much as 10 weeks right into a being pregnant, accessible OTC.

The non-estrogen Opill has been used with prescription because it was FDA-approved in 1973. Perrigo stated scientific proof has proven progestin-only drugs, equivalent to Opill, are efficient at stopping being pregnant and secure for most ladies to make use of.



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