FDA-Approved Generic Mifepristone Tablets, 200 mg, from GenBioPro
The first FDA-approved generic mifepristone tablets, 200 mg, (equivalent to Mifeprex®) are available to you from GenBioPro. They are used in combination with misoprostol for safe and effective medical abortion.
Medical Abortion for Early Intervention
Medical abortion is an FDA-approved method to end a pregnancy within 70 days from the first day of your patient’s last menstrual period. This abortion method is non-invasive – using pills – and is an alternative to an aspiration procedure and anesthesia. It has been used safely and effectively in the US for more than 20 years.
- Effective: 97% successful overall when taken in combination with misoprostol.
- Non-Invasive: The pills are taken orally and buccally.
- On Your Patient’s Terms: Patients can decide where and when to take the mifepristone and misoprostol.
- Flexible For Your Practice: You can decide whether to stock the medication or send prescriptions to a certified pharmacy.
See the Important Safety Information below for the most common side effects experienced by patients.
Increased Access to Medical Abortion
As a result of safety data and clear clinical application, the FDA has expanded the use of medical abortion to end early pregnancies and has made changes to prescribing and dispensing guidelines.
2016 changes included:
- Reduced Dosage. The revised label specified a 200 mg dose of mifepristone, versus the previous 600 mg.
- Expanded Treatment Window. Medical abortion became available for your patients up to 70 days from the first day of their last menstrual period.
- Prescriber Privilege. In addition to physicians, medical professionals with prescribing privileges in their state could become mifepristone providers.
- Fewer Required Visits. The revised label reduced unnecessary return visit requirements for patients.
Changes for 2023 include:
- Removal of the In-Person Prescribing Requirement. In addition to in-person care, telemedicine care is now available in states where it is permitted, increasing access for patients and flexibility for prescribers.
- Expanded Dispensing Options. Certified prescribers now have the flexibility to choose how to dispense mifepristone — directly to patients in their practice or by sending a prescription to a certified pharmacy to be filled. The roster of certified pharmacies includes those with options for filling prescriptions by mail and in-store pick up. Prescribers can elect to work in the way that best suits the needs of their patients and their practice.
- Simplified, Portable Prescriber Agreement. The Prescriber Agreement has been updated; becoming a certified prescriber is now even more simple and straightforward. The Prescriber Agreement is portable, yours alone, and can be used wherever you practice and prescribe.
How Does Mifepristone Work?
Mifepristone, used in combination with misoprostol, is very effective in ending early pregnancy. Mifepristone blocks the production of progesterone, a hormone needed to prepare the uterine lining for successful implantation of a fertilized egg and sustain a pregnancy. As part of a medical abortion, mifepristone is followed by misoprostol, a prostaglandin that induces uterine contractions, which expel the pregnancy.
Mifepristone is used for patients seeking an abortion whose pregnancy is within 70 days from the first day of their last menstrual period. During the patient's consult, a health care provider prescribes one mifepristone 200 mg tablet to be taken orally and four misoprostol 200 mcg tablets, to be taken buccally 24-48 hours after the mifepristone. Patients may experience cramps, nausea, diarrhea, or other symptoms, so they may benefit from medicine or prescriptions for these side effects.
The pregnancy is likely to pass within 2-24 hours after ingestion of the misoprostol. During this process, the patient can expect cramping and heavy bleeding. Spotting may follow and may last for several days. Seven to 14 days after taking the mifepristone and misoprostol, follow up with the patient to confirm that the abortion was successful. If the medical abortion was not successful, discuss an aspiration procedure to ensure pregnancy termination. Although mifepristone and misoprostol are very effective at terminating a pregnancy, about 2 to 7 out of 100 patients taking mifepristone tablets will need an aspiration procedure to end the pregnancy or to address excessive bleeding.
Prescribing Generic Mifepristone Tablets, 200 mg
Mifepristone tablets, 200 mg, from GenBioPro are available only under an FDA-administered Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program requires that all GenBioPro prescribers complete and sign our Prescriber Agreement.
- If you or prescribers under your supervision will dispense mifepristone tablets, 200 mg, in your health care practice directly to patients, send your completed Prescriber Agreement to the email or fax number listed on the form.
- If any prescribers in your practice will send generic mifepristone 200 mg tablet prescriptions to a certified pharmacy, each prescriber must send a completed Prescriber Agreement to the certified pharmacy of their choice.
Additionally, the REMS program requires that prescribers secure a signed Patient Agreement from each patient.
GenBioPro mifepristone tablets, 200 mg, are FDA-approved and equivalent to the branded product. Both are equally safe and effective for medical abortion up to 70 days gestation.
AB rated to: Mifeprex®
ANDA Number: 091178
Date of FDA Approval: 04/11/2019
Ingredients: A light yellow tablet containing 200mg of mifepristone. Inactive ingredients include colloidal silicon dioxide, corn starch, povidone, microcrystalline cellulose and magnesium stearate.
Storage Information: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
Tablet Description: The tablet is light yellow in color, circular, biconvex, and is intended for oral administration only.
Additional Information: For adverse event and product quality complaints, please call 1-855-MIFEINFO (1-855-643-3463).
GenBioPro generic mifepristone tablets, 200 mg, are packaged in provider-friendly sizes.
|Carton (1 individually blistered tablet)
|2¾” x 1⅛” x 1¾”
|Clinic Pack (6 cartons)
|4⅛” x 3¼” x 3½”