Making generic mifepristone available and accessible today
A new generic mifepristone product is coming soon. Evita Solutions LLC's Mifepristone Tablets, 200 mg was approved for use by the US Food and Drug Administration (FDA) in September 2025 for terminating an early pregnancy, up to 70 days from the first day of the last menstrual period.
A new FDA-approved generic mifepristone product coming soon
Mifepristone Tablets, 200 mg is used in combination with misoprostol for safe, effective medical abortion.
Medical abortion is 97% effective when Mifepristone Tablets, 200 mg is taken in combination with misoprostol. Mifepristone blocks the hormone needed for pregnancy to continue, and misoprostol causes contractions to expel the pregnancy from the body. Mifepristone has been approved for use in the U.S. since 2000.
For Providers
Mifepristone Tablets, 200 mg is only available under the FDA-approved Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. In order to prescribe Mifepristone Tablets, 200 mg, all providers are required to complete and sign our Prescriber Agreement and return a copy to our distributor to dispense Mifepristone Tablets, 200 mg directly, or to the certified pharmacy of your choice for pharmacy dispensing. Providers must meet the requirements of the Mifepristone REMS Program, which ensures certified prescribers will properly dispense and supervise dispensing of mifepristone.
For Pharmacists
Mifepristone is available only under the FDA-approved Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. To become a certified pharmacy and begin filling prescriptions for Evita Solutions LLC's Mifepristone Tablets, 200 mg, a pharmacy must be able to meet the requirements of the Mifepristone REMS Program. Certified pharmacies will be able to better serve their clients with pharmacy-friendly packaging, simple ordering processes, and timely order fulfillment.
For Patients
Evita Solutions supports your decision about your pregnancy. If you choose to end a pregnancy, you have several options available. Medical abortion with mifepristone is an effective, safe way to terminate early pregnancy. Mifepristone Tablets, 200 mg is available with a prescription from certified healthcare providers, which you may obtain from an in-person visit or by telemedicine, if it's permitted where you seek abortion care. Your healthcare provider may give you a dose of Mifepristone Tablets, 200 mg or they may write a prescription to be filled by a certified pharmacy. Your prescription may require in-store pick-up or may be shipped by mail, depending on the certified pharmacy. Mifepristone Tablets, 200 mg is not available over the counter.
We know reproductive rights are human rights
Medical abortion care is rife with medically unnecessary restrictions and social stigma in the United States. As a result, many people who choose to end a pregnancy may struggle to get the necessary care they need.
Evita Solutions believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live. We know that you can make the best choice for your body.
Our Mission
We are committed to supporting individuals in making health care decisions by ensuring high-quality and affordable products, accurate information, and a trusted network of prescribers are available, when and where they are needed. Through our work, we assist the medical community in recognizing the utility and freedom that medical abortion provides patients, we seek to normalize abortion care, and we commit to making care accessible to all.
Our Vision
We envision a world where all people are empowered to exercise choice and self-determination.
Accessible healthcare for all
Empowered decision-making
Global reproductive rights
Important Safety Information
Mifepristone tablets, 200 mg, is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.
WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING
Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including Mifepristone Tablets, 200 mg use. No causal relationship between the use of Mifepristone Tablets, 200 mg and misoprostol and these events has been established.
- Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.
- Bleeding. Prolonged and heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.
Because of the risks of serious complications detailed above, Mifepristone Tablets, 200 mg is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Mifepristone REMS Program.
Before prescribing mifepristone, inform the patient about the risk of these serious events. Ensure the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if they experience sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if they experience abdominal pain or discomfort, or general malaise (including weakness, nausea, vomiting, or diarrhea) for more than 24 hours after taking misoprostol.
Contraindications
Administration of Mifepristone Tablets, 200 mg and misoprostol for the termination of pregnancy (the "treatment procedure") is contraindicated in patients with any of the following conditions:
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
- Chronic adrenal failure (risk of acute adrenal insufficiency)
- Concurrent long-term corticosteroid therapy (risk of acute adrenal insufficiency)
- History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
- Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
- Inherited porphyrias (risk of worsening or of precipitation of attacks)
Use of Mifepristone Tablets, 200 mg and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device ("IUD") in place (the IUD might interfere with pregnancy termination). If the IUD is removed, mifepristone tablets, 200 mg may be used.
Warnings and Precautions
Infection and Sepsis
As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of mifepristone tablets, 200 mg. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
A high index of suspicion is needed to rule out sepsis (e.g., from Clostridium sordellii if a patient reports abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting, or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. No causal relationship between Mifepristone Tablets, 200 mg and misoprostol use and an increased risk of infection or death has been established. Clostridium sordellii infections have also been reported very rarely following childbirth (vaginal delivery and caesarian section), and in other gynecologic and non-gynecologic conditions.
Uterine Bleeding
Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick, full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications, and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.
Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more. In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.
Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in patients who bleed heavily.
Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfusions. Based on data from several large clinical trials, vasoconstrictor drugs were used in 4.3% of all subjects, there was a decrease in hemoglobin of more than 2 g/dL in 5.5% of subjects, and blood transfusions were administered to ≤ 0.1% of subjects. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.
Mifepristone REMS Program
Mifepristone tablets, 200 mg is available only through a restricted program under a REMS called the Mifepristone REMS Program, because of the risks of serious complications.
Notable requirements of the Mifepristone REMS Program include the following:
- Prescribers must be certified with the program by completing the Prescriber Agreement Form.
- Patients must sign a Patient Agreement Form.
- Mifepristone tablets, 200 mg must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber.
Further information is available at 866-718-0098.
Ectopic Pregnancy
Mifepristone tablets, 200 mg is contraindicated in patients with a confirmed or suspected ectopic pregnancy because mifepristone is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy. The presence of an ectopic pregnancy may have been missed even if the patient underwent ultrasonography prior to being prescribed Mifepristone tablets, 200 mg.
Patients who became pregnant with an IUD in place should be assessed for ectopic pregnancy.
Rhesus Immunization
The use of Mifepristone Tablets, 200 mg is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.
Adverse Reactions
Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.
For additional information about mifepristone, see the Full Prescribing Information, including Boxed Warning.