Perrigo’s HRA Pharma Submits Software to FDA for First-Ever OTC Beginning Management Capsule

Perrigo's HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill

, /PRNewswire/ — Perrigo Firm plc (NYSE: PRGO), a number one international supplier of Shopper Self-Care Merchandise, at the moment introduced that HRA Pharma, a Perrigo firm, has submitted its utility to america Meals and Drug Administration (FDA) for the first-ever over-the-counter (OTC) contraception capsule in america.

Perrigo Company. (PRNewsfoto/Perrigo Company plc)

Perrigo Firm. (PRNewsfoto/Perrigo Firm plc)

The corporate has utilized for an Rx-to-OTC change for Opill®, a progestin-only each day contraception capsule (additionally known as a mini capsule or non-estrogen capsule). If accredited, this is able to be the primary each day contraception capsule out there OTC with no prescription within the U.S.

“This historic utility marks a groundbreaking second in contraceptive entry and reproductive fairness within the U.S.,” mentioned Frédérique Welgryn, Chief Strategic Operations and Innovation Officer at HRA Pharma. “Greater than 60 years in the past, prescription contraception capsules within the U.S. empowered ladies to plan if and once they wish to get pregnant. Shifting a protected and efficient prescription contraception capsule to OTC will assist much more ladies and other people entry contraception with out going through pointless obstacles.”

Nearly half of the greater than 6.1 million pregnancies within the U.S. every year are unintended1. Entry to a spread of strategies and methods to entry contraception that meet folks’s wants will enhance the chance of utilizing efficient contraception strategies.

Main medical organizations, together with the American Faculty of Obstetricians and Gynecologists, the American Medical Affiliation, and the American Academy of Household Physicians, have expressed help for shifting contraception capsules OTC.

Opill® consists of 0.075 mg norgestrel and has been used to stop being pregnant in hundreds of thousands of girls within the U.S. because it was FDA accredited in 1973. Almost fifty years of use and scientific proof present that progestin-only capsules like Opill® are efficient at stopping being pregnant and are protected 2,3 for most ladies to make use of. As a each day common contraceptive, Opill® is for use pre-conception to be efficient at stopping being pregnant.

Almost one-third of grownup U.S. ladies who’ve ever tried to acquire a prescription or refill for contraceptive capsule, patch, or ring reported difficulties doing so4.

Eradicating the prescription requirement with Opill® would enhance entry to a contraceptive methodology that’s nicely tolerated and notably simpler at stopping being pregnant than all present strategies out there OTC.

“As a physician, I’m devoted to empowering folks to make selections about being pregnant prevention. For a lot of, a contraception capsule could also be the best choice for them however requiring a prescription is an pointless impediment that may put it out of attain,” mentioned obstetrician-gynecologist, Melissa J. Kottke, MD, MPH, MBA. “Eradicating the prescription requirement for a progestin-only contraception capsule will likely be a historic development for being pregnant prevention and a exceptional achievement in group public well being.”

  1. Finer LB, Zolna MR. Declines in unintended being pregnant in america, 2008–2011. N Engl J Med. 2016;374: 843-852

  2. White Ok, Potter JE, Hopkins Ok, Fernandez L, Amastae J, Grossman D. Contraindications to progestin-only oral contraceptive capsules amongst reproductive-aged ladies. Contraception 2012; 86(3): 199-203

  3. American Faculty of Obstetricians and Gynecologists. Over-the-counter entry to hormonal contraception: ACOG committee opinion, Quantity 788. Obstet Gynecol 2019;134(4):e96-e105

  4. Grindlay Ok, Grossman D. Prescription contraception entry amongst U.S. ladies susceptible to unintended being pregnant. J Womens Well being. 2016;25(3): 249-254

About Perrigo

Perrigo Firm plc (NYSE; PRGO) is a number one supplier of Shopper Self-Care Merchandise and over-the-counter (OTC) well being and wellness options that improve particular person well-being by empowering shoppers to proactively forestall or deal with circumstances that may be self-managed. Go to Perrigo on-line at

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