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Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation

… Mifeprex (mifepristone) and its generic Mifepristone Tablets, 200 mg (collectively mifepristone) are approved, in a regimen with misoprostol, to …

Mifepristone (Mifeprex)

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifepristone-mifeprex

… because of the particular facts and circumstances in the mifepristone approval, the agency has determined that release … FDA Archive … Center for Drug Evaluation and Research … Mifepristone (Mifeprex) …

Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation

… On this page: General Information The Mifepristone REMS Program Additional Information Litigation … January 2023 REMS Modification General Information What is mifepristone and how does it work? Mifepristone is a drug that blocks a hormone called …

New York Woman Sentenced for Selling Abortion-Inducing Pills Illegally Smuggled Into US

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/new-york-woman-sentenced-selling-abortion-inducing-pills-illegally-smuggled-us

… Secret Bodega,” where she sold foreign-sourced versions of Mifepristone and Misoprostol from India, that were not … terminate an early pregnancy (up to 70 days or less). Mifepristone is a prescription drug, but is not available to … qualified, licensed physicians, and the administration of Mifepristone is subject to an FDA Risk and Evaluation …

Mifepristone Tablets, 200 mg Medication Guide

https://www.fda.gov/media/164654/download

… 16 MEDICATION GUIDE Mifepristone (MIF-eh-pris-tone) tablets, 200 mg for oral use Read this information carefully before taking Mifepristone tablets, 200 mg and misoprostol. It will help … What is the most important information I should know about Mifepristone tablets, 200 mg? What symptoms should I be …

Mifepristone Tablets, 200 mg Label Information

https://www.fda.gov/media/164653/download

… do not include all the information needed to use MIFEPRISTONE TABLETS, 200 mg safely and effectively. See full prescribing information for Mifepristone tablets, 200 mg. MIFEPRISTONE tablets, 200 mg for oral use Initial U.S. …

Mifepristone AE Summary Table Update Through December 2022

https://www.fda.gov/media/164331/download

… TTT # 2022-2468 NDA 020687 ANDA 091178 Mifepristone U.S. Post-Marketing Adverse Events Summary … adverse events that occurred among patients who had taken mifepristone for medical termination of pregnancy. Because … events cannot with certainty be causally attributed to mifepristone because of information gaps about patient health …

Aidaccess.org - 575658 - 03/08/2019

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aidaccessorg-575658-03082019

… you can do the online consultation. The abortion pills mifepristone and misoprostol will be delivered to you by mail." By facilitating the sale of unapproved mifepristone and misoprostol to consumers in the U.S., … facilitates the sale to U.S. consumers of unapproved mifepristone in a regimen with unapproved misoprostol labeled …

Rablon - 1111111 - 03/08/2019

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rablon-1111111-03082019

… pregnancy." There is an FDA-approved prescription mifepristone drug product that is marketed in the U.S. under … " This is particularly concerning because FDA-approved mifepristone indicated for medical termination of early … safety measures that are put in place for FDA-approved mifepristone indicated for medical termination of early …

Index to Drug-Specific Information

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/index-drug-specific-information

… Micardis (telmisartan) Midodrine Mifeprex (mifepristone) Mifepristone Mirapex (pramipexole) Mirtazapine Misoprostol …

Communigal Communication Ltd - abortionpillrx.net

https://www.fda.gov/consumers/communigal-communication-ltd-abortionpillrxnet