The Food and Drug Administration has approved Emzahh (norethindrone tablets) for the prevention of pregnancy.

Emzahh is an AB-rated generic equivalent of Ortho Micronor®. The progestin-only contraceptive is supplied as 0.35mg tablets in a pack of 28 tablets. One tablet is taken daily at the same time; administration is continuous with no interruption between pill packs.

The first-year failure rate for progestin-only oral contraceptives has been reported to be 0.3% when used perfectly. Typical failure rate has been estimated to be approximately 9% due to late or omitted pills.

Progestin-only pills are contraindicated in patients with known or suspected pregnancy, known or suspected carcinoma of the breast, undiagnosed abnormal genital bleeding, benign or malignant liver tumors, and active liver disease.

In 2022, the FDA determined that Ortho Micronor was withdrawn from the market for business reasons and not for reasons of safety or effectiveness. This determination allowed the FDA to approve the abbreviated New Drug Application for Emzahh.

References

  1. Aurobindo receives FDA approval for Emzahh (norethindrone tablets USP), 0.35mg. News release. January 10, 2023. Accessed January 24, 2023. https://www.aurobindousa.com/news/product-news/aurobindo-receives-fda-approval-for-emzahh-norethindrone-tablets-usp-0-35mg/.
  2. The Federal Register. Determination that MICRONOR (norethindrone tablets, 0.35 milligram) was not withdrawn from sale for reasons of safety or effectiveness. A notice by the Food and Drug Administration. June 30, 2022. Accessed January 24, 2023. https://www.federalregister.gov/documents/2022/06/30/2022-13958/determination-that-micronor-norethindrone-tablets-035-milligram-was-not-withdrawn-from-sale-for.