Mifeprex (mifepristone) Information - U.S. Food and Drug Administration
Jan 17, 2025 · Mifeprex (mifepristone) and its generic, Mifepristone Tablets, 200 mg (collectively mifepristone) are approved, in a regimen with misoprostol, to end an intrauterine pregnancy through ten...
Before you take Mifeprex, you should read this Medication Guide and you and your healthcare provider should discuss the benefits and risks of your using Mifeprex. What is Mifeprex? Mifeprex...
Mifepristone (Mifeprex) | FDA - U.S. Food and Drug Administration
However, because of the particular facts and circumstances in the mifepristone approval, the agency has determined that release of certain information may pose a risk of danger to the lives or...
Updated Mifepristone REMS Requirements - ACOG
On January 3, 2023, updates to the U.S. Food and Drug Administration (FDA) risk evaluation and mitigation strategy (REMS) for mifepristone for reproductive health indications went into effect.
Mifepristone is a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy (IUP) through 70 days gestation. Mifepristone is available...
Mifeprex (mifepristone) Tablets are approved with a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU), which restricts its use.
Mifepristone: Uses, Dosage, Side Effects, Warnings - Drugs.com
Aug 2, 2024 · U.S. Food and Drug Administration. Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation. Korlym Package Insert
FDA finalizes rule expanding availability of abortion pills : NPR
Jan 4, 2023 · WASHINGTON — The Food and Drug Administration on Tuesday finalized a rule change that broadens availability of abortion pills to many more pharmacies, including large chains and mail-order...
The Public Health Implications of the FDA Update to the …
Jun 30, 2016 · On March 29, 2016, the U.S. Food and Drug Administration (FDA) approved updated labeling for mifepristone (also known as the abortion pill or by its brand name, Mifeprex®), which is prescribed along with another medication, misoprostol, for medication abortion in the United States.
U.S. Food and Drug Administration—Applicability of the …
Jul 6, 2023 · In January 2023, the U.S. Food and Drug Administration (FDA) revised the risk evaluation and mitigation strategy for the drug mifepristone. Food and Drug Administration, Risk Evaluation and Mitigation Strategy (REMS) Single Shared System for Mifepristone 200 mg.