FDA Approves New Dosing for Abortion Pill

On Wednesday, March 30th, FDA approved a new label for Mifeprex® (mifepristone), the medical abortion pill. The FDA stated that the drug is both safe and effective when taken in lower doses and up to 70 days after a woman’s last period.

Mifeprex, the branded product for mifepristone, was originally approved by the FDA in 2000. The drug was approved to abort a pregnancy when taken in combination with misoprostol within 49 days of a woman’s last period. Mifepristone works by blocking the necessary hormones, and is administered with misoprostol, which is used to induce contractions to start what many women compare to a heavy period. The product’s original labeling specified a dose of 600 mg, but as doctors figured out that they could achieve the same results with a much lower dose and fewer side effects, many doctors began prescribing mifepristone at a dose of just 200 mg.

In May 2015, Danco Laboratories, manufacturer of Mifeprex, submitted a supplemental new drug application (sNDA) to FDA for a 200 mg dose of the drug. Earlier this week, the FDA approved the sNDA. In addition to a lower dose of the drug, the approved sNDA also prolongs the period of time in which it can be used, extending it from 49 days after a woman’s last menstrual period to 70 days.

FDA states that it is still necessary to have a REMS program for Mifeprex in order to ensure that the product is used safely.

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