FDA-Approved Generic Mifepristone Is Now Available
The first FDA-approved generic mifepristone (equivalent to Mifeprex®) is now available from GenBioPro. It is 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 15 years.
- Safe and Effective: 97% successful overall when taken in combination with misoprostol.
- Non-Invasive: Abortion pill taken orally, instead of an aspiration procedure.
Increased Access to Medical Abortion
In 2016, the FDA expanded the use of medical abortion to end early pregnancies as a result of safety data and clear clinical application.
- Reduced Dosage. The revised label specifies a 200mg dose of mifepristone, versus the previous 600mg.
- Expanded Treatment Window. Medication abortion is available for your patients up to 70 days from the first day of their last menstrual period.
- Prescriber Privilege. Purchase and administration of mifepristone is now allowed for medical professionals who have been granted prescribing privileges in their state.
- Fewer Required Visits. The revised label reduced unnecessary return visit requirements for patients.
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 for patients seeking an abortion whose pregnancy is within 70 days from the first day of their last menstrual period. During the patient's clinic visit, a health care provider administers one mifepristone tablet and either provides or prescribes four misoprostol tablets, to be taken buccally 24-48 hours after the mifepristone. Misoprostol may cause cramps, nausea, diarrhea, or other symptoms, so patients may benefit from medicine or prescriptions for these side effects.
The pregnancy is likely to pass within 2-24 hours after the administration 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
Mifepristone is available only under an FDA-administered Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program requires that all GenBioPro providers complete and return our Prescriber Agreement, secure a signed Patient Agreement from each patient, and agree that a certified prescriber will dispense or supervise dispensing to patients in medical facilities.
GenBioPro generic mifepristone is FDA-approved and equivalent to the branded product you are already using for safe and effective medical abortion.
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); exclusions 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 is packaged in provider-friendly sizes.
|43393-001-01||Carton (1 individually blistered tablet)||2” x ½” x 4”|
|43393-001-06||Clinic Pack (6 cartons)||5” x 2” x 4”|