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 every day contraception capsule for over-the-counter (OTC) sale, the primary such request for this sort of contraception.
The appliance from the HRA comes on the again of the U.S. Supreme Court docket’s choice in June to overturn the 1973 Roe v. Wade case that legalized abortion nationwide. learn extra

The contraceptive is at the moment a prescription drug offered beneath 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’ve got 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 optimistic.

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

At the moment, the one contraception medicine out there for ladies with out a prescription are emergency oral tablets 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, out there 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 tablets, 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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