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What is Mifeprex and how does it work?

  1. Mifeprex (mifepristone) is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. Mifeprex or its approved generic Mifepristone Tablets, 200 mg, when used together with another medicine called misoprostol,
  2. Is there a generic version of Mifeprex?
  3. The FDA approved GenBioPro, Inc.’s abbreviated new drug application (ANDA) for generic Mifeprex on April 11, 2019. This approval reflects FDA’s determination that GenBioPro’s product, Mifepristone Tablets, 200 mg,
  4. Who should not take Mifeprex?
  1. Some women should not take Mifeprex. A woman should not take Mifeprex if it has been more than 70 days since the first day of her last menstrual period, or if she:
  • has an ectopic pregnancy (a pregnancy outside of the uterus)
  • has problems with the adrenal glands (the glands near the kidneys)
  • It also, has had an allergic reaction to mifepristone, misoprostol or similar drugs
  • has bleeding problems or is taking anticoagulant (blood thinning) drug products
  • And Also, has inherited porphyria
  1. This information applies equally to the approved generic version of Mifeprex.
  2. What changes to the Mifeprex application did the FDA approve on March 29, 2016?
  1. The FDA first approved Mifeprex in 2000. In 2016, the agency approved a supplemental application submitted by the drug company that markets Mifeprex. This approval included changes in the dose of Mifeprex and the dosing regimen for taking Mifeprex and misoprostol (including the dose of misoprostol and a change in the route of misoprostol administration from oral to buccal (in the cheek pouch), the interval between taking Mifeprex and misoprostol, and the location at which the woman may take misoprostol).
  2.  Mifeprex (mifepristone) Information On April 11, 2019, FDA approved a supplemental application for Mifeprex, approving modifications to the existing approved REMS for Mifeprex to establish a single, shared system REMS for mifepristone products (including Mifeprex as well as the approved generic version of Mifeprex) for the medical termination of intrauterine pregnancy through 70 days gestation.
  3. Find approval information for this 2019 supplement 
  1. The approved generic version of Mifeprex generally has the same labeling as Mifeprex. As discussed below (see question 8), the approved generic version of Mifeprex is required to use the single, shared system REMS with the brand product, Mifeprex.
  2. What determination related to the Mifepristone REMS Program did FDA announce on December 16, 2021?
  1. After conducting a review of the single, shared system Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, known as the Mifepristone REMS Program, FDA determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks. The modifications to the Mifepristone REMS Program will consist of:
  • Adding a requirement that pharmacies that dispense the drug be certified

  1. What is the most important information I should know about Mifeprex?
  2. What symptoms should I be concerned with? Although cramping and bleeding are an expected part of ending a pregnancy, rarely, serious and potentially life-threatening bleeding, infections, or other problems can occur following a miscarriage, surgical abortion, medical abortion, or childbirth. Serious infection has resulted in death in a very small number of cases. There is no information that use of Mifeprex and misoprostol caused these deaths.
  3. How far into my pregnancy can I have an abortion?
  1. Texas law allows you to have a surgical abortion up to 20 weeks (5 months) into your pregnancy, unless you have severe health problems or there is a fetal abnormality. Texas law measures pregnancy by gestational age, but most clinics measure by last menstrual period (LMP). Usually 20 weeks gestational age is about 22 weeks LMP, so some clinics in Texas offer abortions until 21.6 weeks LMP. The abortion pill, or medication abortion, is only available until about nine weeks into your pregnancy, and is not offered by all clinics.


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