FDA to review first ever over-the-counter birth control pill

July 11 (Reuters) – Perrigo Firm (PRGO.N) stated on Monday its unit HRA Pharma has requested the U.S. Meals and Drug Administration (FDA) to approve a day by day contraception tablet for over-the-counter (OTC) sale, the primary such request for any such contraception.
The appliance 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. learn extra

The contraceptive is at present a prescription drug bought underneath model Opill.

HRA Pharma expects the regulator to carry an advisory committee assembly and approve the applying 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. Now we have been engaged on that utility 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 Faculty of Obstetricians and Gynecologists, stated the submission was a constructive.

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

Presently, the one contraception medication obtainable for girls with no prescription are emergency oral capsules 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, obtainable OTC. learn extra

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

Reporting by Leroy Leo in Bengaluru; Enhancing by Krishna Chandra Eluri and Shinjini Ganguli

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