GENERIC MIFEPRISTONE IS HERE
Please see Important Safety Information below.
As of January 3, 2023, the US Food & Drug Administration (FDA) approved changes to the Risk Evaluation and Mitigation Strategy (REMS) program for generic mifepristone tablets, 200 mg. In addition to maintaining the current system of distribution, the new REMS will improve access by incorporating the following changes:
- Removing the requirement for in-person dispensing, allowing telemedicine care in states that permit it.
- Allowing mail and in-person dispensing from certified pharmacies.
- Streamlining the Prescriber Agreement so that it can be used wherever a health care provider practices and prescribes.
- Clarifying the REMS program guidelines and updating the full prescribing information and the Medication Guide.
GenBioPro helps customers understand how the new REMS program for mifepristone tablets, 200 mg, creates flexibility for health care practices. To learn more, contact us.
New for 2023: Increased Access and Flexibility
The US Food and Drug Administration (FDA) has approved changes to the Risk Evaluation and Mitigation Strategy (REMS) program governing generic mifepristone tablets, 200 mg. Updated distribution guidelines provide new options for the provision of safe and effective medical abortion care, including:
- Removing the Requirement for In-Person Care
In addition to in-person care, telemedicine care is available in states where it is permitted, increasing access for patients and flexibility for prescribers.
- Expanded Dispensing Options
Certified prescribers will now have the flexibility to choose how to provide mifepristone tablets, 200 mg — through direct in-clinic dispensing 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, for in-store pick-up, or both. Prescribers can elect to work directly with patients for dispensing or with the certified pharmacy of their choice, in the way that best suits their own and their patients’ needs.
- Simplified, Portable Prescriber Agreement
The GenBioPro Prescriber Agreement has been updated; becoming a certified GenBioPro prescriber is now even more simple and straightforward. The Prescriber Agreement is portable, yours alone, and can be used wherever you practice and prescribe. New prescribers who wish to dispense directly to patients will need to open an account with the distributor. New prescribers who wish to send prescriptions to a pharmacy will need to send a Prescriber Agreement to the certified pharmacy of their choice. Current prescribers who dispense in-clinic only are already all set — you can continue offering this care and your organization’s operations will remain uninterrupted. You will need to update your Prescriber Agreement and we will contact you about how the modified REMS and its requirements affect your practice.
Medical Abortion & Mifepristone
Medical abortion is an FDA-approved method to end a pregnancy while it is still in its early stage. It involves taking two types of pills: mifepristone, which blocks a hormone needed for a pregnancy to continue, and misoprostol, which causes contractions to expel the pregnancy. Until 2019, when GenBioPro launched its generic medication, mifepristone tablets, 200 mg, were only available in the US as a branded product. The introduction of GenBioPro generic mifepristone tablets, 200 mg, has expanded access to safe and effective medical abortion through stabilized product supply, improved packaging, seamless ordering, and timely fulfillment.
Medical abortion has been used safely and effectively in the US for more than 20 years. In 2016, the FDA approved labeling changes that expanded who may prescribe mifepristone, as well as the window of time it may be used by patients for a safe and effective abortion – currently 70 days from the first day of the last menstrual period. In 2023, other changes have further increased access and flexibility — with a simplified and portable Prescriber Agreement, approval of telemedicine care in states where it is permitted, and expansion to dispensing through certified pharmacies in addition to in-clinic prescriber distribution. In the US, an increasing number of people are choosing medical abortion to end an unwanted pregnancy.
Prescribed or provided confidentially
in a health care setting.
FDA-Approved Generic Mifepristone Tablets, 200 mg, from GenBioPro
Mifepristone tablets, 200 mg, from GenBioPro, the first FDA-approved generic medical abortion pills in the US, are available to health care providers and their patients through in-person care as well as through telemedicine care in states where it is permitted. Prescribers may elect to dispense directly to patients or have prescriptions filled by a certified pharmacy. With this increased flexibility, prescribers can choose the best method of dispensing for their own and their patients' needs.
The FDA determined that GenBioPro generic mifepristone tablets, 200 mg, are equivalent to the branded drug. Medical practices can benefit from stable product supply, provider-friendly packaging with seamless ordering, as well as expanded dispensing options with mifepristone tablets, 200 mg, from GenBioPro.
If you are a health care provider who would like to learn more about prescribing mifepristone tablets, 200 mg, or the recent labeling changes and how they affect you and your patients, see our Prescribing Mifepristone page.
Let's Work Together
GenBioPro is an innovative pharmaceutical company dedicated to putting reproductive health care within reach. We are excited to work with the community of health care providers to improve access to care. We invite you to enroll in the GenBioPro Prescriber Program and enjoy these benefits:
Advocacy for Access
We believe that access to reproductive health care is a fundamental human right. We are dedicated to decreasing barriers, increasing access, and advocating for health care providers and patients alike.
We understand the needs of both small and large practices and are committed to bringing products to market that will make reproductive health care providers more effective in serving their patients.
Improve Patient Experience
Leverage our patient support materials. GenBioPro provides easy-to-read, patient-friendly “before and after” instructions, in print and downloadable formats, and in multiple languages, for use in your practice.
Get Started Now with GenBioPro Generic Mifepristone Tablets, 200 mg
Download your Prescriber Agreement here. Read, sign, and a GenBioPro Representative will contact you directly once your account is established and you are authorized to begin ordering product. Or provide your signed Prescriber Agreement to the certified pharmacy of your choice. Click here to see a list of available certified pharmacies. Either way, that’s all it takes to become a certified GenBioPro Prescriber.