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The FDA first approved Mifeprex in 2000. In 2016, (+966505195917)the FDA updated and approved a new evidence-based regimen and drug label, which guides current clinical practice. (+966505195917)This regimen approves use of medical abortions for up to 70 days (10 weeks) of pregnancy (Table 1). (+966505195917)Until 2019, mifepristone was only sold under the brand name Mifeprex, manufactured by Danco Laboratories. In 2019, the FDA approved GenBioPro, Inc.’s application for generic mifepristone.(+966505195917)
Misoprostol-Only Regimen (+966505195917)While the combined regimen of mifepristone and misoprostol for medication abortion is recommended, there is a second medication abortion protocol using misoprostol–(+966505195917)only that is more commonly used internationally and currently not approved by the FDA. (+966505195917)The regimen is also recommended for up to 70 days (10 weeks) of pregnancy. It involves taking 800 µg (4 pills) of misoprostol sublingually or vaginally every three hours for a total of 12 pills. (+966505195917)Research has shown the misoprostol-only regimen to be a safe and highly effective method of pregnancy termination, (+966505195917)however it may result in a higher incidence of side effects, particularly diarrhea, fever and chills. When taken, the misoprostol-only regimen successfully terminates the pregnancy approximately 80-100% of the time, (+966505195917)with a complication rate of less than 1%. Some U.S. (+966505195917)telehealth organizations have been providing the misoprostol-only regimen as an option for medication abortion for a number of years.(+966505195917)
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